Effect of high-dose vs standard-dose multivitamin supplementation at the initiation of HAART on HIV disease progression and mortality in Tanzania: a randomized controlled trial.

CONTEXT: Large randomized trials have previously shown that high-dose micronutrient supplementation can increase CD4 counts and reduce human immunodeficiency virus (HIV) disease progression and mortality among individuals not receiving highly active antiretroviral therapy (HAART); however, the safety and efficacy of such supplementation has not been established in the context of HAART. OBJECTIVE: To test the hypothesis that high-dose multivitamin supplementation vs standard-dose multivitamin supplementation decreases the risk of HIV disease progression or death and improves immunological, virological, and nutritional parameters in patients with HIV initiating HAART. DESIGN, SETTING, AND PARTICIPANTS: A randomized, double-blind, controlled trial of high-dose vs standard-dose multivitamin supplementation for 24 months in 3418 patients with HIV initiating HAART between November 2006 and November 2008 in 7 clinics in Dar es Salaam, Tanzania. INTERVENTION The provision of daily oral supplements of vitamin B complex, vitamin C, and vitamin E at high levels or standard levels of the recommended dietary allowance. MAIN OUTCOME MEASURE: The composite of HIV disease progression or death from any cause. RESULTS: The study was stopped early in March 2009 because of evidence of increased levels of alanine transaminase (ALT) in patients receiving the high-dose multivitamin supplement. At the time of stopping, 3418 patients were enrolled (median follow-up, 15 months), and there were 2374 HIV disease progression events and 453 observed deaths (2460 total combined events). Compared with standard-dose multivitamin supplementation, high-dose supplementation did not reduce the risk of HIV disease progression or death. The absolute risk of HIV progression or death was 72% in the high-dose group vs 72% in the standard-dose group (risk ratio [RR], 1.00; 95% CI, 0.96-1.04). High-dose supplementation had no effect on CD4 count, plasma viral load, body mass index, or hemoglobin level concentration, but increased the risk of ALT elevations (1239 events per 1215 person-years vs 879 events per 1236 person-years; RR, 1.44; 95% CI, 1.11-1.87) vs standard-dose supplementation. CONCLUSION In adults receiving HAART, use of high-dose multivitamin supplements compared with standard-dose multivitamin supplements did not result in a decrease in HIV disease progression or death but may have resulted in an increase in ALT levels. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT00383669.

Dyslipidemia in an HIV-positive antiretroviral treatment-naive population in Dar es Salaam, Tanzania.

Limited data are available on dyslipidemia in HIV-infected patients in resource-limited settings. We performed a cross-sectional analysis in antiretroviral therapy (ART)-naive, non-fasting HIV-infected patients in Tanzania between November 2004 to June 2008. Robust linear regression modeling was performed. Lipid parameters were assessed in 12,513 patients [65% women; median (interquartile range) age, 36 (30-42) years; CD4 count, 143 (51-290) cells/mm]. Low high-density lipoprotein was prevalent in 67% and increased triglyceride in 28%. High triglyceride and low high-density lipoprotein levels were associated with low CD4 counts (P < 0.001). In this ART-naive Tanzanian population, dyslipidemia was highly prevalent and associated with advanced disease. The impact of ART on these changes requires further exploration.

Etiology of genital ulcer disease and association with human immunodeficiency virus infection in two tanzanian cities.

BACKGROUND: The etiological agent is usually not established in cases of genital ulcer disease (GUD) in Tanzania, since diagnosis and treatment of this disease are based mainly on clinical rather than microbiologic parameters. GUD increases the risk of infection with HIV. However, the association between specific GUD infections and HIV infection has not been fully investigated. GOAL: The goal was to determine the etiology of GUD and the prevalence of HIV infection in patients with GUD in urban areas of Tanzania. STUDY DESIGN: A total of 102 clinical specimens were collected from 52 and 50 patients with GUD in Dar es Salaam and Mbeya, respectively, and from 93 patients with genital discharge in a cross-sectional study. Two polymerase chain reaction (PCR) assays were used to identify either a single target DNA or all three DNAs of the major causes of GUD: Haemophilus ducreyi, Treponema palladum and herpes simplex virus type 2 (HSV-2). The sera from all patients were tested for antibodies to HIV and T palladum. RESULTS: In Dar es Salaam, DNA from HSV-2, and was detected in 63%, 13%, and 2%, respectively, of the 52 genital ulcer specimens. The corresponding figures in Mbeya were 34%, 10%, and 0% of 50 specimens. Overall, 9% of the 102 patients with GUD were infected with both HSV-2 and, and 39/102 genital ulcer specimens (38%) were negative for the DNA of all three pathogens. The HIV infection rates among GUD patients were 46% and 52% in Dar es Salaam and Mbeya, respectively; among the non-GUD patients, the corresponding rates were 35% and 45%, respectively. The HIV infection rate in Dar es Salaam was significantly higher among women (11/14; 78%) than among men (13/38; 34%) (P = 0.004). Among the HIV-seropositive GUD patients, 71% and 46% (P < 0.003) were coinfected with HSV-2 in Dar es Salaam and Mbeya, respectively. Furthermore, women with HSV-2 in Dar es Salaam were significantly more likely to be HIV-infected than men (60% versus 39%; P