Protocol No: ECCT/18/05/03 Date of Protocol: 16-08-2017

Study Title:

Antiretroviral Therapy for Acute or Early HIV Infection

Study Objectives:
1.To describe the impact of Genvoya® initiated during acute or early HIV infection on virologic outcomes, including virologic suppression.
2. To describe the safety and tolerability of Genvoya® administered during acute or early HIV infection.
Laymans Summary:

The main purpose of this research study is to find how a type of HIV treatment works and how safe and tolerable the treatment is for a newly HIV-infected person.  HIV drugs, also called ART, stop HIV from growing in your body. New research suggests that giving ART early may be better as it may mean there is less chance for the virus to grow in the body.  Other research shows that given these HIV drugs early may help the body fight the virus better in the future. For this study, the HIV drugs are combined into one pill called Genvoya. It contains three HIV drugs known as elvitegravir, emtricitabine, tenofovir, alafenamide and a fourth drug known as cobicistat that helps one of the HIV drugs work better. Genvoya is an accepted treatment for HIV infection by the United States Drug Authority (US FDA) but is not yet approved for use in Kenya

A total of up to 100 participants will be enrolled in Kenya, Ugand and Tanzania with up to 33 participants being enrolled in Kericho. These will include adults aged 18-50 years enrolled at the time of early or acute HIV infection . Participants are followed for a total of 96 weeks.In the event that one of the other sites participating in this study cannot meet their enrollment, KEMRI WRP CRC may enroll more participants
Abstract of Study:

The Human Immunodeficiency Virus (HIV) epidemic presents the most serious infectious disease threat worldwide. The global incidence of new human immunodeficiency virus (HIV) infections peaked in the mid-1990s, and a reduction in this incidence has been observed. In 2012 there were 2.3 million new cases, down from 3.4 million in 2001. The reduction of HIV incidence is due to multiple factors that include prevention and treatment programs. The wider availability of antiretroviral therapy (ART), prevention of mother-to-child transmission programs, and a diverse array of other interventions have all contributed to turning the tide of the epidemic. Early, potent control of viral replication by antiretroviral therapy has the potential to preserve critical HIV-specific immune and general immune system function as well as to mitigate the long-term effects of immune activation. This study is a prospective, open-label clinical trial to describe the effects of early antiretroviral (ART) therapy on viral load, immunologic and clinical outcomes and HIV-specific immune responses. Genvoya® (a fixed dose combination of Elvitegravir, tenofovir alefenamide, emtricitabine and cobicistat) is the ART regimen to be used in this study. The study will also assess the safety and tolerability of Genvoya® in treatment of acute infections. Potential volunteers will be recruited from the RV 217 (KEMRI SSC# 1576) cohort if they have been diagnosed with incident HIV Infection. A total of 75 -100 participants will be enrolled and these will include adults aged 18-50 years enrolled at the time of early or acute HIV infection in Kericho, Kenya; Kampala, Uganda; and Mbeya, Tanzania. Participants are followed for a total of 96 weeks.