A Prospective, Single-Arm, Open-Label Study to Evaluate the Effect of Fixed-Dose Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate on T-Cell Activation, Absolute CD4+ T-Cell Count, Inflammatory Biomarkers and Viral Reservoir in Treatment-Na´ve HIV-1 Controllers
This study is being done with people who are infected with HIV, but do not show any signs of having HIV. They are also feeling well without taking HIV medication and have low or undetectable levels of the virus in the blood. The purpose of this study is to see if taking HIV medication (antiretroviral therapy [ART]) will reduce immune activation (a signal that the body is fighting an infection) in people who have HIV, but do not show symptoms. Also this study will help determine how safe the drug is and how well people react to the drug. For this study, the following antiretroviral therapy (ART) will be provided in the form of a single tablet that contains three different drugs: emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF). These drugs are combined as one tablet which is approved by the Food and Drug Administration (FDA) as a single pill to treat HIV infection. The HIV medication provided is one of the recommended treatments for HIV, including people with low viral loads (how much HIV you have in your body) who are taking HIV drugs for the first time. The risks seen with this HIV medication are the same that one would encounter when taking these drugs outside of the study.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : Emtricitabine/rilpivirine/tenofovir disoproxil fumarate
Phase: Phase 4
Ages Eligible For Study:
Step 1 - HIV-1 infection - ART-na´ve defined as ?7 days of ARV treatment at any time prior to entry Documentation of HIV-1 RNA <500 copies/mL verified by at least two measurements prior to the screening RNA specimen - Screening HIV-1 RNA <500 copies/mL using an US FDA-approved assay obtained within 60 days prior to study entry by any laboratory that has a CLIA certification or its equivalent - Laboratory values obtained within 60 days prior to entry by any laboratory that has a CLIA certification or its equivalent: - Absolute neutrophil count (ANC) >=500/mm3 - Hemoglobin >=8.0 g/dL - Platelet count >=40,000/mm3 - Aspartate aminotransferase (AST) (SGOT), alanine aminotransferase (ALT) (SGPT), and alkaline phosphatase <=5 X Upper Limit of Normal (ULN) - Total bilirubin <=2.5 X ULN - Calculated creatinine clearance (CrCl) >=60 mL/min - For females of reproductive potential, negative serum or urine pregnancy test within 48 hours prior to study entry by any laboratory that has a CLIA certification or its equivalent. Female subjects of reproductive potential, who are participating in sexual activity that could lead to pregnancy, must agree to use at least one reliable form of contraceptive (ie, condoms (male or female) with or without a spermicidal agent; a diaphragm or cervical cap with spermicide; an IUD; or hormone-based contraceptive) while receiving the protocol-specified treatment and for 6 weeks after stopping the medications. - No evidence of any exclusionary resistance mutations based on results from any genotype assay from any laboratory that has a CLIA certification or its equivalent Step 2 - Completion of Step 1. - Ability and willingness of subject to choose to receive either open-label ART FDC (FTC/RPV/TDF) or no study treatment for an additional 48 weeks. - For females of reproductive potential, negative serum or urine pregnancy test within 48 hours prior to the week 60 visit by any laboratory that has a CLIA certification or its equivalent.