Ongoing Studies

MK8527-010

A Phase 3, Randomized, Active-Controlled, Double-blind Clinical Study To Evaluate the Efficacy And Safety Of MK-8527 Oral Once-Monthly As HIV-1 Preexposure Prophylaxis in Women

The Study is carried out in countries of South Africa, Kenya and Uganda.

Objectives
1. To evaluate the efficacy of oral MK-8527 QM compared to FTC/TDF QD for the prevention of HIV-1 infection as assessed by as assessed by the incidence rate per year of adjudicated HIV-1 infections

2. To evaluate the safety and tolerability of oral MK-8527 QM compared to oral FTC/TDF QD

PURPOSE 1 Study

PURPOSE 1 which stands for Phase 3, Double- Blinded, Multicenter, Randomized Study to Evaluate Safety and Efficacy of Twice Yearly Long- Acting Subcutaneous Lenacapavir, and Daily Oral Emtricitabine/ Tenofovir Alafenamide for Pre- Exposure Prophylaxis in Adolescent Girls and Young Women at Risk of HIV Infection started in 2022 and has the main objective of evaluating the efficacy of lenacapavir (LEN) and emitricitabine/ tenofovir alafenamide (F/TAF) in preventing the risk of HIV-1 infection relative to the background HIV-1 incidence rate. 

The PURPOSE 1 study includes a cross-sectional study which has the Incidence phase, the Randomized phase a LEN Open Label Extension phase and Pharmacokinetic Tail Phase.
The PURPOSE I study in partnership with Gilead Sciences, Inc. is based in approximately 25 centers in South Africa and Uganda. In Uganda there are three sites that work on the PURPOSE study namely; Makerere- Kalangala, AMBSO and MUJHU with each site recruiting a total number of 250 cisgender Adolescent Girls and Young Women at risk of acquiring HIV-1 infection from the age of 16 to 25 years.

The study objectives are;

  • The primary objective of the Incidence phase of the study is to estimate the HIV-1 background incidence rate.
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The primary objective of the Randomized phase of the study is;

  • To evaluate the efficacy of LEN for HIV-1 pre-exposure prophylaxis (PrEP) in Adolescent girls and Young Women at risk of HIV-1 infection
  • To evaluate the efficacy of F/TAF for HIV-1 PrEP in AGYW at risk of HIV-1 infection.

PALLISADE STUDY

UVRI-CRP Initiative ( formerly UVRI-IAVI HIV Vaccine Program) started implementing ( PALISADE study ) a Long-Term Follow-Up study of Cabotegravir long-acting (CAB LA) for Participants in HPTN 083 and HPTN 084 CAB PrEP Studies at Risk of HIV Acquisition sponsored by ViiV Healthcare UK Limited on 17 Jan 2025
The primary objective is to describe new HIV infections in adult and adolescent participants at risk of HIV acquisition included in the HPTN 083 and HPTN 084 studies and their associated sub-studies.