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Safety and Tolerability of Maraviroc-Containing Regimens to Prevent HIV Infection in Women: A Phase 2 Randomized Trial.

  • Author(s): 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
  • et al.

Published Web Location

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5667908/pdf/nihms909749.pdf
No data is associated with this publication.
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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