Study of Viral Load Decay Rates in HIV Infected Participants Starting Treatment With Raltegravir (RAL) and Emtricitabine/Tenofovir Disoproxil Fumarate (TDF)
- Conditions
- HIV Infections
- Interventions
- Registration Number
- NCT00660972
- Brief Summary
The HIV integrase inhibitor, raltegravir (RAL), which was recently approved by the FDA, has been shown in several trials to be highly effective. The purpose of this trial is to estimate the viral load decay rate in treatment-naive HIV infected participants receiving RAL and emtricitabine/tenofovir disoproxil fumarate (FTC/TDF).
- Detailed Description
Recent data suggests that early virologic response to HIV interventions may be predictive of long-term virologic outcomes. Defining early decay in viral load through carefully performed studies of viral dynamics may be a useful tool for assessing the likely outcome of long-term treatment. It may also be a useful screening tool to define which combinations should be studied further. In this trial, the viral load decay rate will be estimated in HIV infected, treatment-naive participants receiving RAL and FTC/TDF.
This study will last approximately 72 weeks. All participants will take RAL and FTC/TDF for 72 weeks. RAL will be provided by the study. FTC/TDF will not be provided.
This study will consist of 16 study visits. These visits will occur at study entry, Days 2, 7, 10, 14, 21, 28, and 56, and Weeks 12, 16, 20, 24, 36, 48, 60, and 72. Blood collection and pharmacokinetic studies will occur at all study visits. Self-reported adherence assessments will be submitted at each visit. A targeted physical exam will occur at most visits. Liver function tests and urine collection will occur at select visits. Pregnancy tests will occur whenever pregnancy is suspected.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- HIV infected
- Antiretroviral treatment naive
- Viral load at least 10,000 and less than 300,000 copies/ml within 42 days prior to study entry
- Agree to use appropriate form of contraception. More information on this criterion can be found in the protocol.
- Received HIV-specific immunizations within 6 months prior to study entry
- Received immunizations within 6 months prior to study entry
- Known allergy or sensitivity to study drugs
- Any participant with an acute AIDS-defining opportunistic infection (OI) who is not clinically stable or who has not been on therapy for the OI for at least 30 days prior to study entry
- Treatment with immune modulators or any investigational therapy within 30 days prior to study entry
- Evidence of HIV seroconversion within 6 months prior to study entry
- Illness requiring systemic treatment and/or hospitalization
- Substance abuse that, in the opinion of the investigator, would interfere with adherence to study requirements
- Requirement for any current medications that are prohibited with any study medication. More information on this criterion can be found in the protocol.
- Evidence of any major resistance-associated mutation on any genotype performed prior to study entry or at the time of screening. More information on this criterion can be found in the protocol.
- Abnormal laboratory values. More information on this criterion can be found in the protocol.
- Pregnant or breastfeeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Emtricitabine/tenofovir disoproxil fumarate Oral RAL and FTC/TDF for 72 weeks 1 Raltegravir Oral RAL and FTC/TDF for 72 weeks
- Primary Outcome Measures
Name Time Method Viral load decay rates Through Day 56
- Secondary Outcome Measures
Name Time Method Viral load From Week 24 to Week 72 Viral load decay rates From Weeks 24 to 72 Proportion of participants with a viral load less than 50 copies/ml At Weeks 24, 48, and 72 CD4 and CD8 count Throughout study Changes in viral load At Day 7 Self-reported adherence Throughout study Safety and tolerability. More information on this criterion can be found in the protocol. Throughout study Cell-associated proviral DNA, LTR circular DNA, and integrated proviral DNA Throughout study Resistance mutations to RAL, FTC, and TDF Throughout study Minimum concentration (Cmin) for RAL, FTC, and TDF Throughout study
Trial Locations
- Locations (15)
Northwestern University CRS
🇺🇸Chicago, Illinois, United States
IHV Baltimore Treatment CRS
🇺🇸Baltimore, Maryland, United States
Ohio State University CRS
🇺🇸Columbus, Ohio, United States
Johns Hopkins University CRS
🇺🇸Baltimore, Maryland, United States
UCSD Antiviral Research Center CRS
🇺🇸San Diego, California, United States
Brigham and Women's Hospital Therapeutics Clinical Research Site (BWH TCRS) CRS
🇺🇸Boston, Massachusetts, United States
Houston AIDS Research Team CRS
🇺🇸Houston, Texas, United States
Vanderbilt Therapeutics (VT) CRS
🇺🇸Nashville, Tennessee, United States
University of Colorado Hospital CRS
🇺🇸Aurora, Colorado, United States
Washington University Therapeutics (WT) CRS
🇺🇸Saint Louis, Missouri, United States
Trillium Health ACTG CRS
🇺🇸Rochester, New York, United States
Harlem ACTG CRS
🇺🇸New York, New York, United States
Univ. of Rochester ACTG CRS
🇺🇸Rochester, New York, United States
MetroHealth CRS
🇺🇸Cleveland, Ohio, United States
The Miriam Hospital Clinical Research Site (TMH CRS) CRS
🇺🇸Providence, Rhode Island, United States