Status:
COMPLETED
Study of Viral Load Decay Rates in HIV Infected Participants Starting Treatment With Raltegravir (RAL) and Emtricitabine/Tenofovir Disoproxil Fumarate (TDF)
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Adult AIDS Clinical Trials Group
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
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 vir...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00660972
Start Date
May 1 2008
End Date
April 1 2010
Last Update
November 1 2021
Active Locations (15)
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1
UCSD Antiviral Research Center CRS
San Diego, California, United States, 92103
2
University of Colorado Hospital CRS
Aurora, Colorado, United States, 80045
3
Northwestern University CRS
Chicago, Illinois, United States, 60611
4
IHV Baltimore Treatment CRS
Baltimore, Maryland, United States, 21201