FTC/RPV/TDF on T-Cell Activation, CD4+ T-Cell Count, Inflammatory Biomarkers and Viral Reservoir
Status:
Completed
Trial end date:
2017-02-07
Target enrollment:
Participant gender:
Summary
This study was done with people who were infected with HIV, but did not show any signs of
having HIV. They were also feeling well without taking HIV medication and had low or
undetectable levels of the virus in the blood. The purpose of this study was to see if taking
HIV medication (antiretroviral therapy [ART]) would reduce immune activation (a signal that
the body is fighting an infection) in people who have HIV, but did not show symptoms. Also
this study helped determine how safe the drug was and how well people reacted to the drug.
For this study, the following antiretroviral therapy (ART) was be provided in the form of a
single tablet that contains three different drugs: emtricitabine/rilpivirine/tenofovir
disoproxil fumarate (FTC/RPV/TDF). These drugs were combined as one tablet which was approved
by the Food and Drug Administration (FDA) as a single pill to treat HIV infection. The HIV
medication provided was one of the recommended treatments for HIV, including people with low
viral loads (how much HIV you have in your body) who were taking HIV drugs for the first
time. The risks seen with this HIV medication were the same that one would encounter when
taking these drugs outside of the study.
Phase:
Phase 4
Details
Lead Sponsor:
AIDS Clinical Trials Group
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)