Overview

This trial is active, not recruiting.

Condition hiv-1 infection
Treatment emtricitabine/rilpivirine/tenofovir disoproxil fumarate
Phase phase 4
Sponsor AIDS Clinical Trials Group
Collaborator National Institute of Allergy and Infectious Diseases (NIAID)
Start date February 2013
End date February 2016
Trial size 57 participants
Trial identifier NCT01777997, 1U01AI068636, ACTG A5308

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Step 1 From entry through week 12 the participants will receive no study treatment. From week 12 through week 60, the participants will receive one FTC/RPV/TDF (200mg/25mg/300mg) tablet orally once daily with a meal. Step 2 (Optional) From week 60 through Week 108, the participants will either receive one FTC/RPV/TDF (200mg/25mg/300mg)table orally once daily with a meal or no study treatment.
emtricitabine/rilpivirine/tenofovir disoproxil fumarate FTC/RPV/TDF

Primary Outcomes

Measure
Change in levels of CD8+ T-cell activation (defined as the percentage HLA-DR+/CD38+) from baseline to weeks 24 and 48 on ART
time frame: From baseline to week 48 on ART

Secondary Outcomes

Measure
Plasma HIV-1 RNA level measured by Single Copy Assay (SCA) as above versus below the limit of the assay
time frame: At baseline and weeks 4, 12, 24, 36 and 48 on ART
Change in CD4+ T-cell count
time frame: From baseline to weeks 12, 24, 36 and 48 on ART
Change in levels of CD8+ T-cell activation
time frame: From baseline to weeks 4, 24 and 48 on ART
Change in levels of CD4+ T-cell activation (defined as the percentage HLA-DR+/CD38+)
time frame: From baseline to weeks 4, 24 and 48 on ART
Change in levels of Interleukin (IL)-6
time frame: From baseline to weeks 4, 24 and 48 on ART
Change in levels of 2D-dimer
time frame: From baseline to weeks 4, 24 and 48 on ART
Change in quality of life (QoL) index
time frame: From baseline to weeks 4, 24 and 48 on ART
Number of subjects who experience Grade 3 or 4 signs and symptoms or laboratory abnormalities, diagnoses, or other serious adverse events (SAEs)
time frame: From baseline through week 48 on ART

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: Step 1 - HIV-1 infection - ART-naïve 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. Exclusion Criteria: Step 1 - Chronic hepatitis B virus (HBV) infection (documented by hepatitis B surface antigen (HBsAg) seropositivity) - Breastfeeding - Use of immunomodulators (eg, interleukins, interferons, cyclosporine), topical imiquimod, HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy within 30 days prior to study entry or plans to start immunomodulators, topical imiquimod, HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy during the study - Known allergy/sensitivity or any hypersensitivity to components of study drug(s) or their formulation - Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements - Acute or serious illness requiring systemic treatment and/or hospitalization within 30 days prior to entry - Symptomatic HIV disease and/or AIDS-defining illness. - Vaccinations within 7 days prior to study entry - Plans to initiate hepatitis C treatment during the study - Perinatally-acquired HIV - Use of any of the following medications within 7 days prior to study entry: - St. John's wort (Hypercium perforatum) - Anticonvulsants (eg, oxacarbazepine, phenobarbital, phenytoin) - Anti-infectives (eg, rifabutin, rifampin, rifapentine) - Corticosteroids (eg, dexamethasone (more than 1 dose)) - Proton pump inhibitors (eg, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole) Step 2 - Plans to start immunomodulators, topical imiquimod, HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy during Step 2 of the study. - Plans to initiate hepatitis C treatment during Step 2 of the study. NOTE: Please refer to the protocol for detailed eligibility criteria.

Additional Information

Official title 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-Naïve HIV-1 Controllers
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by AIDS Clinical Trials Group.