Phase I trial of pod-intravaginal rings delivering antiretroviral agents for HIV-1 prevention: Rectal drug exposure from vaginal dosing with tenofovir disoproxil fumarate, emtricitabine, and maraviroc.
Kathleen Listiak VincentJohn A MossMark A MarzinkeCraig W HendrixPeter A AntonManjula GunawardanaLauren N DawsonTrevelyn J OliveRichard B PylesMarc M BaumPublished in: PloS one (2018)
The concentrations of FTC and MVC in rectal fluids obtained in two exploratory clinical trials of IVRs delivering ARV combinations exceeded levels associated with in vitro efficacy in HIV inhibition. Unexpectedly, MVC appeared to depress the distribution of TFV and FTC into the rectal lumen. Here we show that vaginal delivery of ARV combinations may provide adherence and coitally independent dual-compartment protection from HIV infection during both vaginal and receptive anal intercourse.
Keyphrases
- antiretroviral therapy
- hiv infected
- hiv positive
- clinical trial
- human immunodeficiency virus
- hiv aids
- rectal cancer
- hiv infected patients
- men who have sex with men
- hiv testing
- phase ii
- phase iii
- hepatitis c virus
- study protocol
- high grade
- randomized controlled trial
- south africa
- metabolic syndrome
- open label
- glycemic control
- insulin resistance
- adipose tissue
- adverse drug