FTC/RPV/TDF on T-Cell Activation, CD4+ T-Cell Count, Inflammatory Biomarkers and Viral Reservoir
Trial Summary
What is the purpose of this trial?
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.
Research Team
Jonathan Li, M.D., M.M.S.
Principal Investigator
Brigham and Women's Hospital Therapeutics (BWHT) CRS
Eligibility Criteria
Inclusion Criteria
Treatment Details
Interventions
- Emtricitabine/rilpivirine/tenofovir disoproxil fumarate (Antiretroviral Therapy)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Lead Sponsor
Dr. Joseph J. Eron Jr.
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Chief Executive Officer
MD from Harvard Medical School
Dr. James McNamara
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Chief Medical Officer since 2023
MD from Harvard Medical School
AIDS Clinical Trials Group
Lead Sponsor
Dr. Diane V. Havlir
AIDS Clinical Trials Group
Chief Executive Officer since 2023
MD from Stanford University
Dr. Wafaa M. El-Sadr
AIDS Clinical Trials Group
Chief Medical Officer since 2023
MD from Columbia University
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Dr. Jeanne Marrazzo
National Institute of Allergy and Infectious Diseases (NIAID)
Chief Executive Officer since 2023
MD, MPH
Dr. H. Clifford Lane
National Institute of Allergy and Infectious Diseases (NIAID)
Chief Medical Officer
MD