Your browser doesn't support javascript.
loading
Show: 20 | 50 | 100
Results 1 - 20 de 50
Filter
Add more filters

Publication year range
1.
Nurs Res ; 2024 May 20.
Article in English | MEDLINE | ID: mdl-38809559

ABSTRACT

BACKGROUND: People experiencing homelessness are at greater risk of exposure and poor health outcomes from COVID-19. Yet, little data exists on the prevalence and correlates of COVID-19 among homeless populations. To mitigate the spread and severity, uptake of the COVID-19 vaccine is needed. This can be challenging among youth experiencing homelessness who are more likely to be unvaccinated when compared to stably housed youth. OBJECTIVE: We conducted this study to determine the prevalence and correlates of COVID-19 among youth experiencing homelessness. METHODS: We examined experiences of COVID-19 symptoms, self-report of infection, rates of COVID-19 antibodies and distinguished between natural and vaccinated immunity among youth experiencing homelessness (N = 265) recruited in one large metropolitan area in the South. RESULTS: Based on self-report, very few participants experienced any symptoms, and 80% had never been diagnosed with COVID-19. Of those with COVID-19 antibodies (68%), the proportion with antibodies resulting from natural infection was 44%. The vaccination rate was 42%. Younger and vaccinated participants and those in shelters were likelier to have COVID-19 antibodies. Black and Hispanic youth were more likely than White youth to have had COVID-19. Those who adopted only one or two prevention behaviors were more likely to acquire a natural infection than those who adopted three or more prevention behaviors. DISCUSSION: Youth experiencing homelessness report low vaccination rates, disrupted access to health care and social supports, and underlying chronic conditions, which may explain why they face poorer outcomes when infected with COVID-19. Vaccination and risk mitigation strategies to combat the high prevalence of COVID-19 are especially needed for sheltered youth who are at high risk yet are often asymptomatic.

2.
Clin Infect Dis ; 75(2): 347-355, 2022 08 25.
Article in English | MEDLINE | ID: mdl-35181789

ABSTRACT

In countries with high human immunodeficiency virus (HIV) prevalence, up to 30% of pregnant women are living with HIV, with fetal exposure to both HIV and antiretroviral therapy during pregnancy. In addition, pregnant women without HIV but at high risk of HIV acquisition are increasingly receiving HIV preexposure antiretroviral prophylaxis (PrEP). Investments are being made to establish and follow cohorts of children to evaluate the long-term effects of in utero HIV and antiretroviral exposure. Agreement on a key set of definitions for relevant exposures and outcomes is important both for interpreting individual study results and for comparisons across cohorts. Harmonized definitions of in utero HIV and antiretroviral drug (maternal treatment or PrEP) exposure will also facilitate improved classification of these exposures in future observational studies and clinical trials. The proposed definitions offer a uniform approach to facilitate the consistent description and estimation of effects of HIV and antiretroviral exposures on key child health outcomes.


Subject(s)
Anti-HIV Agents , HIV Infections , Pre-Exposure Prophylaxis , Pregnancy Complications, Infectious , Anti-HIV Agents/adverse effects , Anti-Retroviral Agents/therapeutic use , Child , Female , HIV , HIV Infections/prevention & control , Humans , Infectious Disease Transmission, Vertical/prevention & control , Pregnancy , Pregnancy Complications, Infectious/drug therapy
3.
Clin Infect Dis ; 73(8): 1388-1396, 2021 10 20.
Article in English | MEDLINE | ID: mdl-33991185

ABSTRACT

BACKGROUND: Men who have sex with men (MSM) are at high risk for human papillomavirus (HPV)-related anal cancer. Little is known about the prevalence of low-grade squamous intraepithelial lesions (LSILs) and the anal cancer precursor, high-grade squamous intraepithelial lesions (HSILs), among young MSM with HIV (MSMLWH). HPV vaccination is recommended in this group, but its safety, immunogenicity, and protection against vaccine-type HPV infection and associated LSILs/HSILs have not been studied. METHODS: Two hundred and sixty MSMLWH aged 18-26 years were screened at 17 US sites for a clinical trial of the quadrivalent (HPV6,11,16,18) HPV (qHPV) vaccine. Those without HSILs were vaccinated at 0, 2, and 6 months. Cytology, high-resolution anoscopy with biopsies of lesions, serology, and HPV testing of the mouth/penis/scrotum/anus/perianus were performed at screening/month 0 and months 7, 12, and 24. RESULTS: Among 260 MSMLWH screened, the most common reason for exclusion was detection of HSILs in 88/260 (34%). 144 MSMLWH were enrolled. 47% of enrollees were previously exposed to HPV16. No incident qHPV type-associated anal LSILs/HSILs were detected among men naive to that type, compared with 11.1, 2.2, 4.5, and 2.8 cases/100 person-years for HPV6,11,16,18-associated LSILs/HSILs, respectively, among those previously exposed to that type. qHPV was immunogenic and safe with no vaccine-associated serious adverse events. CONCLUSIONS: 18-26-year-old MSMLWH naive to qHPV vaccine types were protected against incident qHPV type-associated LSILs/HSILs. Given their high prevalence of HSILs, there is an urgent need to vaccinate young MSMLWH before exposure to vaccine HPV types, before initiating sexual activity, and to perform catch-up vaccination.


Subject(s)
Alphapapillomavirus , Anus Neoplasms , HIV Infections , Papillomavirus Infections , Papillomavirus Vaccines , Sexual and Gender Minorities , Squamous Intraepithelial Lesions , Adolescent , Adult , Anal Canal , Anus Neoplasms/epidemiology , Anus Neoplasms/prevention & control , HIV , HIV Infections/complications , HIV Infections/prevention & control , Homosexuality, Male , Humans , Male , Papillomaviridae/genetics , Papillomavirus Infections/complications , Papillomavirus Infections/epidemiology , Papillomavirus Infections/prevention & control , Prevalence , Sexual Behavior , Vaccination , Young Adult
4.
J Allergy Clin Immunol ; 140(4): 1101-1111.e7, 2017 Oct.
Article in English | MEDLINE | ID: mdl-28279683

ABSTRACT

BACKGROUND: Increased incidence and prevalence of asthma have been documented for perinatally HIV-infected youth 10 to 21 years of age compared with HIV-exposed uninfected (HEU) youth. OBJECTIVE: We sought to perform objective pulmonary function tests (PFTs) in HIV-infected and HEU youth with and without diagnosed asthma. METHOD: Asthma was determined in 370 participants (218 HIV-infected and 152 HEU participants) by means of chart review and self-report at 13 sites. Interpretable PFTs (188 HIV-infected and 132 HEU participants) were classified as obstructive, restrictive, or normal, and reversibility was determined after bronchodilator inhalation. Values for HIV-1 RNA, CD4 and CD8 T cells, eosinophils, total IgE, allergen-specific IgE, and urinary cotinine were measured. Adjusted prevalence ratios (PRs) of asthma and PFT outcomes were determined for HIV-infected participants relative to HEU participants, controlling for age, race/ethnicity, and sex. RESULTS: Current asthma was identified in 75 (34%) of 218 HIV-infected participants and 38 (25%) of 152 HEU participants (adjusted PR, 1.33; P = .11). The prevalence of obstructive disease did not differ by HIV status. Reversibility was less likely in HIV-infected youth than in HEU youth (17/183 [9%] vs 21/126 [17%]; adjusted PR, 0.47; P = .020) overall and among just those with obstructive PFT results (adjusted PR, 0.46; P = .016). Among HIV-infected youth with current asthma, serum IgE levels were inversely correlated with CD8 T-cell counts and positively correlated with eosinophil counts and not associated with CD4 T-cell counts. HIV-infected youth had lower association of specific IgE levels to several inhalant and food allergens compared with HEU participants and significantly lower CD4/CD8 T-cell ratios (suggesting immune imbalance). CONCLUSION: Compared with HEU youth, HIV-infected youth demonstrated decreased reversibility of obstructive lung disease, which is atypical of asthma. This might indicate an early stage of chronic obstructive pulmonary disease. Follow-up into adulthood is warranted to further define their pulmonary outcomes.


Subject(s)
Asthma/immunology , CD4-Positive T-Lymphocytes/immunology , CD8-Positive T-Lymphocytes/immunology , Eosinophils/immunology , HIV Infections/immunology , HIV-1/physiology , Prenatal Exposure Delayed Effects/immunology , Adolescent , Asthma/epidemiology , Female , HIV Infections/epidemiology , Humans , Immunoglobulin E/metabolism , Incidence , Male , Maternal Exposure/adverse effects , Pregnancy , Prenatal Exposure Delayed Effects/epidemiology , Prevalence , Respiratory Function Tests , Time Factors , United States , Viral Load
5.
Am J Public Health ; 106(1): 40-4, 2016 Jan.
Article in English | MEDLINE | ID: mdl-26562103

ABSTRACT

Whether adolescents can participate in clinical trials of pharmacologic therapies for HIV prevention, such as preexposure prophylaxis, without parental permission hinges on state minor consent laws. Very few of these laws explicitly authorize adolescents to consent to preventive services for HIV and other sexually transmitted infections. Unclear state laws may lead to research cessation. We have summarized legal, ethical, and policy considerations related to adolescents' participation in HIV and sexually transmitted infection prevention research in the United States, and we have explored strategies for facilitating adolescents' access.


Subject(s)
Clinical Trials as Topic/legislation & jurisprudence , HIV Infections/prevention & control , Health Policy , Minors/legislation & jurisprudence , Parental Consent/legislation & jurisprudence , Research Subjects/legislation & jurisprudence , Adolescent , Chemoprevention/ethics , Chemoprevention/methods , Clinical Trials as Topic/ethics , HIV Infections/epidemiology , Humans , Parental Consent/ethics , Sexually Transmitted Diseases/epidemiology , Sexually Transmitted Diseases/prevention & control , State Government , United States/epidemiology
6.
AIDS Care ; 26(1): 107-15, 2014 Jan.
Article in English | MEDLINE | ID: mdl-23800360

ABSTRACT

Poor adherence to antiretroviral therapy (ART) contributes to disease progression and emergence of drug-resistant HIV in youth with perinatally acquired HIV infection (PHIV +), necessitating reliable measures of adherence. Although electronic monitoring devices have often been considered the gold-standard assessment in HIV research, they are costly, can overestimate nonadherence and are not practical for routine care. Thus, the development of valid, easily administered self-report adherence measures is crucial for adherence monitoring. PHIV+youth aged 7-16 (n = 289) and their caregivers, enrolled in a multisite cohort study, were interviewed to assess several reported indicators of adherence. HIV-1 RNA viral load (VL) was dichotomized into >/≤ 400 copies/mL. Lower adherence was significantly associated with VL >400 copies/mL across most indicators, including ≥ 1 missed dose in past seven days [youth report: OR = 2.78 (95% CI, 1.46-5.27)]. Caregiver and combined youth/caregiver reports yielded similar results. Within-rater agreement between various adherence indicators was high for both youth and caregivers. Inter-rater agreement on adherence was moderate across most indicators. Age ≥ 13 years and living with biological mother or relative were associated with VL >400 copies/mL. Findings support the validity of caregiver and youth adherence reports and identify youth at risk of poor adherence.


Subject(s)
Anti-HIV Agents/therapeutic use , HIV Infections/drug therapy , Medication Adherence , Viral Load , Adolescent , CD4 Lymphocyte Count , Child , Cross-Sectional Studies , Female , HIV Infections/blood , HIV Infections/virology , Humans , Infectious Disease Transmission, Vertical , Male , Self Report , Socioeconomic Factors , Surveys and Questionnaires , Treatment Outcome
7.
N Engl J Med ; 362(4): 314-9, 2010 Jan 28.
Article in English | MEDLINE | ID: mdl-20107217

ABSTRACT

Live pentavalent human-bovine reassortant rotavirus vaccine is recommended in the United States for routine immunization of infants. We describe three infants, two with failure to thrive, who had dehydration and diarrhea within 1 month after their first or second rotavirus immunization and subsequently received a diagnosis of severe combined immunodeficiency. Rotavirus was detected, by means of reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay, in stool specimens obtained from all three infants, and gene-sequence analysis revealed the presence of vaccine rotavirus. These infections raise concerns regarding the safety of rotavirus vaccine in severely immunocompromised patients.


Subject(s)
Rotavirus Infections/etiology , Rotavirus Vaccines/adverse effects , Rotavirus/isolation & purification , Severe Combined Immunodeficiency/complications , DNA, Viral/analysis , Dehydration/etiology , Diarrhea, Infantile/etiology , Failure to Thrive/etiology , Feces/virology , Female , Humans , Infant , Infant, Newborn , Male , RNA, Viral/analysis , Reverse Transcriptase Polymerase Chain Reaction , Rotavirus/genetics , Rotavirus Infections/virology , Sequence Alignment , Sequence Analysis, DNA , Severe Combined Immunodeficiency/therapy , Stem Cell Transplantation , Virus Shedding
8.
AIDS Behav ; 17(5): 1683-7, 2013 Jun.
Article in English | MEDLINE | ID: mdl-23377704

ABSTRACT

Determine the relationship between food insecurity and CD4 counts and viral suppression among pediatric HIV-positive patients. Food insecurity was assessed by validated survey. CD4 counts and viral load were abstracted from patients' charts. We used linear regression for the dependent variable of the natural log of CD4 counts and logistic regression for viral suppression, with backward deletion of covariates with p > 0.1. Food insecurity (ß = -0.23, 95 % CI [-0.40, -0.01]) was associated with lower CD4 counts and higher odds of incomplete viral suppression (OR = 4.07, 95 % CI [1.02, 13.92]). Food insecurity may adversely impact pediatric HIV outcomes.


Subject(s)
CD4 Lymphocyte Count , Food Supply , HIV Infections/therapy , Viral Load , Adolescent , CD4 Lymphocyte Count/statistics & numerical data , Child , Cross-Sectional Studies , Diet Surveys , Female , Food Supply/statistics & numerical data , HIV Infections/epidemiology , Hospitals, Pediatric/statistics & numerical data , Humans , Linear Models , Logistic Models , Male , Pilot Projects , Texas/epidemiology , Viral Load/statistics & numerical data
9.
J Allergy Clin Immunol ; 129(1): 176-83, 2012 Jan.
Article in English | MEDLINE | ID: mdl-22078471

ABSTRACT

BACKGROUND: Matched related donor (MRD) hematopoietic stem cell transplantation (HSCT) is a successful treatment for chronic granulomatous disease (CGD), but the safety and efficacy of HSCT from unrelated donors is less certain. OBJECTIVE: We evaluated the outcomes and overall survival in patients with CGD after HSCT. METHODS: We report the outcomes for 11 children undergoing HSCT from an MRD (n = 4) or an HLA-matched unrelated donor (MUD) (n = 7); 9 children were boys, and the median age was 3.8 years (range, 1-13 years). We treated both X-linked (n = 9) and autosomal recessive (n = 2) disease. Nine children had serious clinical infections before transplantation. The conditioning regimens contained busulfan, cyclophosphamide, cytarabine, or fludarabine according to the donor used. All patients received alemtuzumab (anti-CD52 antibody). Additional graft-versus-host disease (GvHD) prophylaxis included cyclosporine and methotrexate for MUD recipients and cyclosporine and prednisone for MRD recipients. RESULTS: Neutrophil recovery took a median of 16 days (range, 12-40 days) and 18 days (range, 13-24 days) for MRD and MUD recipients, respectively. Full donor neutrophil engraftment occurred in 9 patients, and 2 had stable mixed chimerism; all patients had sustained correction of neutrophil oxidative burst defect. Four patients had grade I skin acute GVHD responding to topical treatment. No patient had grade II to IV acute GvHD or chronic GvHD. All patients are alive between 1 and 8 years after HSCT. CONCLUSION: For CGD, equivalent outcomes can be obtained with MRD or MUD stem cells, and HSCT should be considered an early treatment option.


Subject(s)
Granulomatous Disease, Chronic/therapy , Hematopoietic Stem Cell Transplantation/mortality , Tissue Donors , Unrelated Donors , Activities of Daily Living , Adolescent , Child , Child, Preschool , Educational Status , Female , Graft vs Host Disease/etiology , Graft vs Host Disease/prevention & control , Granulomatous Disease, Chronic/immunology , Granulomatous Disease, Chronic/mortality , Hematopoietic Stem Cell Transplantation/adverse effects , Humans , Infant , Infant, Newborn , Male , Quality of Life , Sibling Relations , Transplantation, Homologous , Treatment Outcome
10.
Clin Immunol ; 142(2): 201-8, 2012 Feb.
Article in English | MEDLINE | ID: mdl-22094294

ABSTRACT

The incidence of asthma and atopic dermatitis (AD) was evaluated in HIV-infected (n = 451) compared to HIV-exposed (n = 227) but uninfected (HEU) children and adolescents by abstraction from clinical charts. Asthma was more common in HIV-infected compared to HEU children by clinical diagnosis (25% vs. 20%, p = 0.101), by asthma medication use, (31% vs. 22%, p = 0.012), and by clinical diagnosis and/or medication use, (34% vs. 25%, p = 0.012). HIV-infected children had a greater risk of asthma compared to HEU children (HR = 1.37, 95% CI: 1.01 to 1.86). AD was more common in HIV-infected than HEU children (20% vs. 12%, p = 0.009)) and children with AD were more likely to have asthma in both cohorts (41% vs. 29%, p = 0.010). HIV-infected children and adolescents in this study had an increased incidence of asthma and AD, a finding critical for millions of HIV-infected children worldwide.


Subject(s)
Asthma/epidemiology , Dermatitis, Atopic/epidemiology , Disease Susceptibility , HIV Infections/epidemiology , Adolescent , Chi-Square Distribution , Child , Child, Preschool , Cohort Studies , Female , Humans , Infant, Newborn , Male , Pregnancy , Risk Factors
11.
Clin Immunol ; 144(1): 13-23, 2012 Jul.
Article in English | MEDLINE | ID: mdl-22659030

ABSTRACT

Youth infected with HIV at birth often have sleep disturbances, neurocognitive deficits, and abnormal psychosocial function which are associated with and possibly resulted from elevated blood cytokine levels that may lead to a decreased quality of life. To identify molecular pathways that might be associated with these disorders, we evaluated 38 HIV-infected and 35 uninfected subjects over 18-months for intracellular cytokine levels, sleep patterns and duration of sleep, and neurodevelopmental abilities. HIV infection was significantly associated with alterations of intracellular pro-inflammatory cytokines (TNF-α, IFN-γ, IL-12), sleep factors (total time asleep and daytime sleep patterns), and neurocognitive factors (parent and patient reported problems with socio-emotional, behavioral, and executive functions; working memory-mental fatigue; verbal memory; and sustained concentration and vigilance. By better defining the relationships between HIV infection, sleep disturbances, and poor psychosocial behavior and neurocognition, it may be possible to provide targeted pharmacologic and procedural interventions to improve these debilitating conditions.


Subject(s)
Child Behavior Disorders/etiology , Cognition Disorders/etiology , Cytokines/blood , HIV Infections/complications , HIV Infections/physiopathology , Sleep/physiology , Adolescent , CD4-Positive T-Lymphocytes/immunology , CD8-Positive T-Lymphocytes/immunology , Child , Cohort Studies , Executive Function , Female , HIV Infections/blood , HIV Infections/immunology , Humans , Male , Memory/physiology , Neuropsychological Tests
12.
AIDS Care ; 24(3): 310-8, 2012.
Article in English | MEDLINE | ID: mdl-21899488

ABSTRACT

Youth account for almost half of all new HIV infections in the United States. Adherence to antiretroviral treatment (ART) is critical for successful management, yet reported adherence rates for youth are often low. This study pilot-tested "+CLICK," an innovative, web-based, adherence intervention for HIV-positive youth as an adjunct to traditional clinic-based, self-management education. The theory-based application, developed for HIV-infected youth, 13-24 years of age, provides tailored activities addressing attitudes, knowledge, skills, and self-efficacy related to ART adherence. HIV-positive youth (N=10) pilot-tested "+CLICK" to assess usability (ease of use, credibility, understandability, acceptability, motivation) and short-term psychosocial outcomes (importance and self-efficacy related to ART adherence) using a single-group, pre-/post-test study design in a hospital-based pediatric clinic (n=8) and home (n=2) location. Youth were mostly female (80%) and Black (80%). Mean age was 17.8 years (SD=2.65, range 14-22). All were infected perinatally and had been living with HIV all their lives. Most learned their HIV status by age 10 years. Sixty percent reported an undetectable viral load, whilst 10% reported a viral load of over 50,000. Half (50%) reported a normal CD4 count, whilst 20% reported having low CD4 (<200). Usability ratings indicated "+CLICK" was very easy to use (70%), trustworthy, and understandable (both>90%). Most (70%) indicated they would use "+CLICK" again. Short-term psychosocial outcomes indicate significant increase in medication adherence self-efficacy (p<0.05), perceived importance of taking antiretroviral medicine close to the right time every day (p<0.05), and knowledge about HIV and adherence (p<0.01). Other psychosocial variables and behavioral intentions were not significantly impacted. Results suggest that "+CLICK" has the potential to affect psychological antecedents to ART adherence. Further research on long-term and behavioral effects is indicated prior to broader dissemination into clinical practice.


Subject(s)
Anti-Retroviral Agents/therapeutic use , HIV Infections/drug therapy , Health Promotion/methods , Patient Education as Topic/methods , Self Care/methods , Adolescent , Female , HIV Seropositivity/drug therapy , Health Knowledge, Attitudes, Practice , Humans , Internet , Male , Motivation , Pilot Projects , United States , Young Adult
13.
Pediatr Infect Dis J ; 41(1): 57-59, 2022 01 01.
Article in English | MEDLINE | ID: mdl-34609103

ABSTRACT

Thanks to the development of antiretroviral drugs and the implementation of routine perinatal prophylaxis, primarily containing zidovudine, modern-day rates of perinatal transmission of HIV are very low in developed countries. We present a case of perinatal transmission of HIV with extensive nucleoside reverse transcriptase inhibitor resistance as a reminder that perinatal transmission of resistance mutations can occur. This case calls for further investigation into the utility of using genotype to determine neonatal prophylaxis in the setting of maternal HIV drug resistance.


Subject(s)
Anti-HIV Agents/pharmacology , Drug Resistance, Viral , HIV Infections/transmission , HIV-1/drug effects , Infectious Disease Transmission, Vertical , Adult , Anti-HIV Agents/therapeutic use , Female , Genotype , HIV Infections/drug therapy , HIV-1/genetics , Humans , Infant, Newborn , Male , Mothers , Pregnancy , Pregnancy Complications, Infectious/drug therapy , United States
14.
J Acquir Immune Defic Syndr ; 89(3): 303-309, 2022 03 01.
Article in English | MEDLINE | ID: mdl-34732682

ABSTRACT

BACKGROUND: This study evaluated atazanavir and cobicistat pharmacokinetics during pregnancy compared with postpartum and in infant washout samples. SETTING: A nonrandomized, open-label, parallel-group, multicenter prospective study of atazanavir and cobicistat pharmacokinetics in pregnant women with HIV and their children. METHODS: Intensive steady-state 24-hour pharmacokinetic profiles were performed after administration of 300 mg of atazanavir and 150 mg of cobicistat orally in fixed-dose combination once daily during the second trimester, third trimester, and postpartum. Infant washout samples were collected after birth. Atazanavir and cobicistat were measured in plasma by validated high-performance liquid chromatography-ultraviolet and liquid chromatography-tandem mass spectrometry assays, respectively. A 2-tailed Wilcoxon signed-rank test (α = 0.10) was used for paired within-participant comparisons. RESULTS: A total of 11 pregnant women enrolled in the study. Compared with paired postpartum data, atazanavir AUC0-24 was 26% lower in the second trimester [n = 5, P = 0.1875, geometric mean of ratio (GMR) = 0.739, 90% CI: 0.527 to 1.035] and 54% lower in the third trimester (n = 6, GMR = 0.459, P = 0.1563, 90% CI: 0.190 to 1.109), whereas cobicistat AUC0-24 was 35% lower in the second trimester (n = 5, P = 0.0625, GMR = 0.650, 90% CI: 0.493 to 0.858) and 52% lower in the third trimester (n = 7, P = 0.0156, GMR = 0.480, 90% CI: 0.299 to 0.772). The median (interquartile range) 24-hour atazanavir trough concentration was 0.21 µg/mL (0.16-0.28) in the second trimester, 0.21 µg/mL (0.11-0.56) in the third trimester, and 0.61 µg/mL (0.42-1.03) in postpartum. Placental transfer of atazanavir and cobicistat was limited. CONCLUSIONS: Standard atazanavir/cobicistat dosing during pregnancy results in lower exposure which may increase the risk of virologic failure and perinatal transmission.


Subject(s)
Atazanavir Sulfate/pharmacokinetics , HIV Infections , HIV Protease Inhibitors , Pregnancy Complications, Infectious , Anti-HIV Agents , Atazanavir Sulfate/therapeutic use , Child , Cobicistat , Female , HIV Infections/drug therapy , Humans , Infectious Disease Transmission, Vertical , Placenta , Postpartum Period , Pregnancy , Pregnancy Complications, Infectious/drug therapy , Prospective Studies
15.
J Acquir Immune Defic Syndr ; 90(3): 343-350, 2022 07 01.
Article in English | MEDLINE | ID: mdl-35195573

ABSTRACT

BACKGROUND: Tenofovir alafenamide (TAF) is a key component of HIV treatment, but pharmacokinetic data supporting the use of TAF during pregnancy are limited. In this study, we report pharmacokinetic, safety, and birth outcomes for TAF 25 mg with a boosted protease inhibitor in pregnant women living with HIV. METHODS: IMPAACT P1026s was a multicenter, nonrandomized, open-label, phase IV prospective study. Pregnant women living with HIV receiving TAF 25 mg with a boosted protease inhibitor were eligible. Intensive pharmacokinetic assessments were performed during the second and third trimesters and 6-12 weeks postpartum. Maternal and cord blood samples were collected at delivery. Infant washout samples were collected through 5-9 days postbirth. Comparisons of paired pharmacokinetic data between pregnancy and postpartum were made using geometric mean ratios (GMR) [90% confidence intervals (CIs)] and Wilcoxon signed-rank tests with P < 0.10 considered significant. RESULTS: Twenty-nine women were enrolled from the United States (median age 31 years and weight 84.5 kg during the third trimester; 48% Black, 45% Hispanic/Latina). TAF AUCtau did not significantly differ in the second [GMR 0.62 (90% CI: 0.29 to 1.34); P = 0.46] or third trimester [GMR 0.94 (90% CI: 0.63 to 1.39); P = 0.50] vs. postpartum and were comparable with historical data in nonpregnant adults. TAF was only quantifiable in 2/25 maternal delivery samples and below the limit of quantification in all cord blood and infant washout samples, likely because of the short half-life of TAF. CONCLUSION: TAF AUCtau did not significantly differ between pregnancy and postpartum. These findings provide reassurance as TAF use during pregnancy continues to expand.


Subject(s)
Anti-HIV Agents , HIV Infections , Pregnancy Complications, Infectious , Adenine/therapeutic use , Adult , Alanine , Anti-HIV Agents/pharmacokinetics , Anti-HIV Agents/therapeutic use , Antiviral Agents/therapeutic use , Female , HIV Infections/drug therapy , Humans , Postpartum Period , Pregnancy , Pregnancy Complications, Infectious/drug therapy , Prospective Studies , Protease Inhibitors/therapeutic use , Tenofovir/analogs & derivatives
16.
Mhealth ; 7: 38, 2021.
Article in English | MEDLINE | ID: mdl-33898607

ABSTRACT

A number of mobile health (mHealth) interventions have been shown to be effective and highly acceptable tools for improving human immunodeficiency virus (HIV) prevention and care for youth. Scale-up of efficacious technology-based interventions is challenging and best practices for scale-up have not been clearly established. Developers of mHealth interventions should have plans in mind for wide scale implementation throughout all stages of development including planning, during trials and during analysis and dissemination. We discuss an approach of focus on researchers, funders and potential implementers including members of the community, public health practitioners and policymakers during initial planning, trials, analysis and dissemination, and planning for scale-up. Development of the P3 (Prepared, Protected, emPowered) mobile application (app), an intervention built to encourage and increase pre-exposure prophylaxis (PrEP) adherence among young men who have sex with men (YMSM) and young transgender women who have sex with men (YTWSM), is discussed in terms of designing for scale-up and lessons learned.

17.
AIDS ; 35(8): 1191-1199, 2021 07 01.
Article in English | MEDLINE | ID: mdl-34076612

ABSTRACT

OBJECTIVE: To evaluate darunavir and cobicistat pharmacokinetics during pregnancy compared with postpartum and in infant washout samples after delivery. DESIGN: Nonrandomized, open-label, parallel-group, multicenter phase-IV prospective study of darunavir and cobicistat pharmacokinetics in pregnant women with HIV and their children in the United States. METHODS: Intensive steady-state 24-h pharmacokinetic profiles were performed after administration of 800 mg of darunavir and 150 mg of cobicistat orally in fixed dose combination once-daily during the second trimester, third trimester, and postpartum. Infant washout samples were collected after birth. Darunavir and cobicistat were measured in plasma by validated HPLC-UV and liquid chromatography with tandem mass spectrometry detection (LC-MS)/MS assays, respectively. A two-tailed Wilcoxon signed-rank test (α = 0.10) was employed for paired within-participant comparisons. RESULTS: A total of 29 pregnant women receiving darunavir and cobicistat once-daily enrolled in the study. Compared with paired postpartum data, darunavir AUC0--24 was 53% lower in the second trimester [n = 12, P = 0.0024, geometric mean of ratio (GMR)=0.47, 90% confidence interval (CI) 0.33 - 0.68] and 56% lower in the third trimester (n = 18, P < 0.0001, GMR = 0.44, 90% CI 0.36 - 0.54), whereas cobicistat AUC0--24 was 50% lower in the second trimester (n = 12, P = 0.0024, GMR = 0.50, 90% CI 0.36-0.69) and 56% lower in the third trimester (n = 18, P < 0.0001, GMR = 0.44, 90% CI 0.35-0.55). Placental transfer of darunavir and cobicistat was limited. CONCLUSION: Standard darunavir/cobicistat dosing during pregnancy results in significantly lower exposure during pregnancy, which may increase the risk of virologic failure and perinatal transmission.


Subject(s)
Anti-HIV Agents , HIV Infections , Anti-HIV Agents/therapeutic use , Child , Cobicistat/therapeutic use , Darunavir/therapeutic use , Female , HIV Infections/drug therapy , Humans , Infectious Disease Transmission, Vertical , Placenta , Postpartum Period , Pregnancy , Prospective Studies
18.
J Allergy Clin Immunol ; 124(5): 1062-9.e1-4, 2009 Nov.
Article in English | MEDLINE | ID: mdl-19895994

ABSTRACT

BACKGROUND: The effect of pretransplantation conditioning on the long-term outcomes of patients receiving hematopoietic stem cell transplantation for severe combined immunodeficiency (SCID) has not been completely determined. OBJECTIVE: We sought to assess the outcomes of 23 mostly conditioned patients with SCID and compare their outcomes with those of 25 previously reported nonconditioned patients with SCID who underwent transplantation. METHODS: In the present study we reviewed the medical records of these 23 consecutive, mostly conditioned patients with SCID who underwent transplantation between 1998 and 2007. RESULTS: Eighteen patients (median age at transplantation, 10 months; range, 0.8-108 months) received haploidentical mismatched related donor, matched unrelated donor, or mismatched unrelated donor transplants, 17 of whom received pretransplantation conditioning (with 1 not conditioned); 13 (72%) patients engrafted with donor cells and survive at a median of 3.8 years (range, 1.8-9.8 year); 5 (38%) of 13 patients require intravenous immunoglobulin; and 6 of 6 age-eligible children attend school. Of 5 recipients (median age at transplantation, 7 months; range, 2-23 months) of matched related donor transplants, all 5 engrafted and survive at a median of 7.5 years (range, 1.5-9.5 year), 1 recipient requires intravenous immunoglobulin, and 3 of 3 age-eligible children attend school. Gene mutations were known in 16 cases: mutation in the common gamma chain of the IL-2 receptor (IL2RG) in 7 patients, mutation in the alpha chain of the IL-7 receptor (IL7RA) in 4 patients, mutation in the recombinase-activating gene (RAG1) in 2 patients, adenosine deaminase deficiency (ADA) in 2 patients, and adenylate kinase 2 (AK2) in 1 patient. Early outcomes and quality of life of the previous nonconditioned versus the present conditioned cohorts were not statistically different, but longer-term follow-up is necessary for confirmation. CONCLUSIONS: Hematopoietic stem cell transplantation in patients with SCID results in engraftment, long-term survival, and a good quality of life for the majority of patients with or without pretransplantation conditioning.


Subject(s)
Hematopoietic Stem Cell Transplantation , Severe Combined Immunodeficiency/surgery , Transplantation Conditioning , Child , Child, Preschool , Female , Graft vs Host Disease/immunology , Humans , Immunoglobulin A/blood , Immunoglobulin G/blood , Infant , Infant, Newborn , Kaplan-Meier Estimate , Male , Quality of Life , Treatment Outcome
19.
AIDS Care ; 21(5): 622-31, 2009 May.
Article in English | MEDLINE | ID: mdl-19444671

ABSTRACT

Adolescents and young adults account for over 10 million HIV infections worldwide. Prevention of secondary transmission is a major concern as many HIV-positive youth continue to engage in risky sexual behavior. This study pilot-tested " + CLICK", an innovative, web-based, sexual risk reduction intervention for HIV-positive youth as an adjunct to traditional clinic-based, self-management education. The theory-based application, developed for perinatally and behaviorally infected youth 13-24 years of age, provides tailored activities addressing attitudes, knowledge, skills, and self-efficacy related to sexual risk reduction. HIV-positive youth (N=32) pilot-tested " + CLICK" to assess usability (ease of use, credibility, understandability, acceptability, motivation) and short-term psychosocial outcomes (importance and self-efficacy related to abstinence and condom use) using a single group, pre-/post-test study design in a hospital-based pediatric clinic and community locations. A subsample of participants (n=20) assessed feasibility for clinic use. Participants were 62.5% female, 68.8% Black, and 28.1% Hispanic. Mean age was 17.8 years (SD = 2.55), 43.8% were infected behaviorally, 56.2% perinatally, and 68.8% were sexually experienced. Usability ratings were high: 84.4% rated the application very easy to use; 93.8% perceived content as trustworthy; 87.5% agreed most words were understandable; 87.5% would use the application again. Short-term psychosocial outcomes indicate a significant increase in condom use self-efficacy (p=0.008) and positive trends toward importance (p=0.067) and self-efficacy (p=0.071) for waiting before having sex. Regarding feasibility, participants accessed " + CLICK" during waiting periods (average time, 15 minutes) in their routine clinic visit. Clinic staff rated " + CLICK" highly in providing consistent, confidential, and motivational sexual health education without significant disruption to clinic flow. Results suggest that the application is a feasible tool for use in the clinic and has the potential to affect psychological antecedents to sexual behavior change. Further research on long-term and behavioral effects is indicated prior to broader dissemination into clinical practice.


Subject(s)
HIV Infections/prevention & control , Health Promotion/methods , Internet , Patient Education as Topic/methods , Safe Sex/psychology , Self Care/methods , Adolescent , Female , HIV Infections/transmission , Humans , Male , Pilot Projects , Risk Factors , Self Efficacy , Young Adult
20.
J Allergy Clin Immunol ; 122(1): 159-65, 2008 Jul.
Article in English | MEDLINE | ID: mdl-18547627

ABSTRACT

BACKGROUND: Immunoreconstitution of HIV(+) patients after treatment with highly active antiretroviral therapy (HAART) appears to provoke inflammatory diseases. OBJECTIVE: We sought to determine whether HIV(+) children receiving HAART (HIV(+) HAART(+)) have a higher incidence of asthma than HIV(+) children not receiving HAART (HIV(+) HAART(-)). METHODS: Two thousand six hundred sixty-four children (193 HIV(+) and 2471 HIV(-) children) born to HIV(+) women were evaluated for the incidence and prevalence of asthma (ie, asthma medication use) and change of CD4(+) T-cell percentage with time. RESULTS: The HIV(+) HAART(+) children had higher CD4(+) T-cell percentages, lower CD8(+) T-cell percentages, and lower viral burdens than the HIV(+) HAART(-) children (P < or = .05 to P < or = .01). The cumulative incidence of asthma medication use in HIV(+) HAART(+) children at 13.5 years increased to 33.5% versus 11.5% in HIV(+) HAART(-) children (hazard ratio, 3.34; P = .01) and was equal to that in the HIV(-) children. In children born before the HAART era, the prevalence of asthma medication use for HIV(+) HAART(+) children at 11 years of age was 10.4% versus 3.8% for HIV(+) HAART(-) children (odds ratio, 3.38; P = .02) and was equal to that of the HIV(-) children. The rate of change of CD4(+) T cells around the time of first asthma medication for HIV(+) HAART(+) versus HIV(+) HAART(-) children was 0.81%/y versus -1.43%/y (P = .01). CONCLUSION: The increased incidence of asthma in HIV(+) HAART(+) children might be driven by immunoreconstitution of CD4(+) T cells.


Subject(s)
Anti-HIV Agents/therapeutic use , Antiretroviral Therapy, Highly Active , Asthma/epidemiology , CD4-Positive T-Lymphocytes/immunology , CD8-Positive T-Lymphocytes/immunology , HIV Infections/drug therapy , Asthma/etiology , Asthma/immunology , CD4 Lymphocyte Count , Cohort Studies , Female , HIV Infections/immunology , HIV Infections/virology , Humans , Incidence , Infant , Male
SELECTION OF CITATIONS
SEARCH DETAIL