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Safety and Tolerability of Maraviroc-Containing Regimens to Prevent HIV Infection in Women: A Phase 2 Randomized Trial.
Gulick, Roy M; Wilkin, Timothy J; Chen, Ying Q; Landovitz, Raphael J; Amico, K Rivet; Young, Alicia M; Richardson, Paul; Marzinke, Mark A; Hendrix, Craig W; Eshleman, Susan H; McGowan, Ian; Cottle, Leslie M; Andrade, Adriana; Marcus, Cheryl; Klingman, Karin L; Chege, Wairimu; Rinehart, Alex R; Rooney, James F; Andrew, Philip; Salata, Robert A; Siegel, Marc; Manabe, Yukari C; Frank, Ian; Ho, Ken; Santana, Jorge; Stekler, Joanne D; Swaminathan, Shobha; McCauley, Marybeth; Hodder, Sally; Mayer, Kenneth H.
Afiliação
  • Gulick RM; From Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimo
  • Wilkin TJ; From Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimo
  • Chen YQ; From Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimo
  • Landovitz RJ; From Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimo
  • Amico KR; From Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimo
  • Young AM; From Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimo
  • Richardson P; From Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimo
  • Marzinke MA; From Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimo
  • Hendrix CW; From Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimo
  • Eshleman SH; From Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimo
  • McGowan I; From Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimo
  • Cottle LM; From Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimo
  • Andrade A; From Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimo
  • Marcus C; From Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimo
  • Klingman KL; From Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimo
  • Chege W; From Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimo
  • Rinehart AR; From Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimo
  • Rooney JF; From Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimo
  • Andrew P; From Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimo
  • Salata RA; From Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimo
  • Siegel M; From Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimo
  • Manabe YC; From Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimo
  • Frank I; From Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimo
  • Ho K; From Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimo
  • Santana J; From Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimo
  • Stekler JD; From Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimo
  • Swaminathan S; From Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimo
  • McCauley M; From Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimo
  • Hodder S; From Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimo
  • Mayer KH; From Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimo
Ann Intern Med ; 167(6): 384-393, 2017 Sep 19.
Article em En | MEDLINE | ID: mdl-28828489
ABSTRACT

BACKGROUND:

Maraviroc (MVC) is a candidate drug for HIV preexposure prophylaxis (PrEP).

OBJECTIVE:

To assess the safety and tolerability of MVC-containing PrEP over 48 weeks in U.S. women at risk for HIV infection.

DESIGN:

Phase 2 randomized, controlled, double-blinded study of 4 antiretroviral regimens used as PrEP. (ClinicalTrials.gov NCT01505114).

SETTING:

12 clinical research sites of the HIV Prevention Trials Network and AIDS Clinical Trials Group.

PARTICIPANTS:

HIV-uninfected women reporting condomless vaginal or anal intercourse with at least 1 man with HIV infection or unknown serostatus within 90 days. INTERVENTION MVC only, MVC-emtricitabine (FTC), MVC-tenofovir disoproxil fumarate (TDF), and TDF-FTC (control). MEASUREMENTS At each visit, clinical and laboratory (including HIV) assessments were done. Primary outcomes were grade 3 and 4 adverse events and time to permanent discontinuation of the study regimen. All randomly assigned participants were analyzed according to their original assignment.

RESULTS:

Among 188 participants, 85% completed follow-up, 11% withdrew early, and 4% were lost to follow-up; 19% discontinued their regimen prematurely. The number discontinuing and the time to discontinuation did not differ among regimens. Grade 3 or 4 adverse events occurred in 5 (MVC), 13 (MVC-FTC), 9 (MVC-TDF), and 8 (TDF-FTC) participants; rates did not differ among regimens. One death (by suicide) occurred in the MVC-TDF group but was judged not to be related to study drugs. Of available plasma samples at week 48 (n = 126), 60% showed detectable drug concentrations. No new HIV infections occurred.

LIMITATIONS:

Participants were not necessarily at high risk for HIV infection. The regimen comprised 3 pills taken daily. The study was not powered for efficacy.

CONCLUSION:

Maraviroc-containing PrEP regimens were safe and well-tolerated compared with TDF-FTC in U.S. women. No new HIV infections occurred, although whether this was due to study drugs or low risk in the population is uncertain. Maraviroc-containing PrEP for women may warrant further study. PRIMARY FUNDING SOURCE National Institutes of Health.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Triazóis / Infecções por HIV / Cicloexanos / Inibidores da Fusão de HIV / Profilaxia Pré-Exposição Idioma: En Ano de publicação: 2017 Tipo de documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Triazóis / Infecções por HIV / Cicloexanos / Inibidores da Fusão de HIV / Profilaxia Pré-Exposição Idioma: En Ano de publicação: 2017 Tipo de documento: Article