Phase 4
N=38
FTC/RPV/TDF on T-Cell Activation, CD4+ T-Cell Count, Inflammatory Biomarkers and Viral Reservoir
HIV-1 Infection
Bottom Line
View on ClinicalTrials.gov: NCT01777997 ↗Enrolled (actual)
38
Serious AEs
2.8%
Results posted
Jan 2018
Primary outcome: Primary: Change in Levels of CD8+ T-cell Activation (Defined as the Percentage HLA-DR+/CD38+) From Baseline to Weeks 24 and 48 on ART — -4.01 % of CD8+ T-cells — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Emtricitabine/rilpivirine/tenofovir disoproxil fumarate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Levels of CD8+ T-cell Activation (Defined as the Percentage HLA-DR+/CD38+) From Baseline to Weeks 24 and 48 on ART |
-4.01 | 0.001 sig |
| SECONDARY Plasma HIV-1 RNA Level Measured by Single Copy Assay Using Primer in Integrase (iSCA) as the Proportion of Participants Below the Limit of the Assay |
0.19; 0.19; 0.61; 0.90; 0.93; 0.92 | — |
| SECONDARY Change in CD4+ T-cell Count |
-15; -5; 25; 19 | — |
| SECONDARY Change in Levels of CD8+ T-cell Activation |
-0.7; -1.6; -2.2; -4.7 | — |
| SECONDARY Change in Levels of CD4+ T-cell Activation (Defined as the Percentage HLA-DR+/CD38+) |
0.1; -0.1; -0.2; -0.2 | — |
| SECONDARY Change in Levels of Interleukin (IL)-6 |
0.05; 0.01; 0.02; 0 | — |
| SECONDARY Change in Levels of D-dimer |
0.01; 0.01; 0.02 | — |
| SECONDARY Change in Quality of Life (QoL) Index |
0; -0.1; 0 | — |
| SECONDARY Number of Subjects Who Experience Grade 3 or 4 Signs and Symptoms or Laboratory Abnormalities, Diagnoses (Any Grade), or Other Serious Adverse Events (SAEs) |
18 | — |
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.
Eligibility Criteria
Inclusion Criteria
Step 1
- HIV-1 infection
- ART-naïve defined as ≤7 days of antiretroviral (ARV) treatment at any time prior to entry
- Documentation of HIV-1 RNA =500/mm^3
- Hemoglobin >=8.0 g/dL
- Platelet count >=40,000/mm^3
- Aspartate aminotransferase (AST) (SGOT), alanine aminotransferase (ALT) (SGPT), and alkaline phosphatase =60 mL/min
- For females of reproductive potential, negative serum or urine pregnancy test within 48 hours prior to study entry by any clinic or 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 intrauterine device (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 Clinical Laboratory Improvement Amendments (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 clinic or 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.
Data sourced from ClinicalTrials.gov (NCT01777997). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.