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

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Adult AIDS Clinical Trials Group
• Treatments: Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Raltegravir Potassium; Tenofovir

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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