Study of Viral Load Decay Rates in HIV Infected Participants Starting Treatment With Raltegravir (RAL) and Emtricitabine/Tenofovir Disoproxil Fumarate (TDF)

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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).

Key facts

Study ID

NCT00660972

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

40

Starts

2008-05-01

Expected to finish

2010-04-01

Last updated by the study team

2021-11-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• UCSD Antiviral Research Center CRS — San Diego, California, United States
• University of Colorado Hospital CRS — Aurora, Colorado, United States
• Northwestern University CRS — Chicago, Illinois, United States
• IHV Baltimore Treatment CRS — Baltimore, Maryland, United States
• Johns Hopkins University CRS — Baltimore, Maryland, United States
• Brigham and Women's Hospital Therapeutics Clinical Research Site (BWH TCRS) CRS — Boston, Massachusetts, United States
• Washington University Therapeutics (WT) CRS — St Louis, Missouri, United States
• Harlem ACTG CRS — New York, New York, United States
• Trillium Health ACTG CRS — Rochester, New York, United States
• Univ. of Rochester ACTG CRS — Rochester, New York, United States
• MetroHealth CRS — Cleveland, Ohio, United States
• Ohio State University CRS — Columbus, Ohio, United States
• The Miriam Hospital Clinical Research Site (TMH CRS) CRS — Providence, Rhode Island, United States
• Vanderbilt Therapeutics (VT) CRS — Nashville, Tennessee, United States
• Houston AIDS Research Team CRS — Houston, Texas, United States

Full record on ClinicalTrials.gov

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