Safety and Effectiveness of Raltegravir Plus Darunavir/Ritonavir in Treatment-Naive HIV-Infected Adults

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the effectiveness and safety of an antiretroviral therapy (ART) regimen consisting of raltegravir (RAL) and darunavir (DRV)/ritonavir (RTV) as first-line therapy in treatment-naïve participants.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AIDS Clinical Trials Group
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Darunavir; Raltegravir Potassium; Ritonavir

Criteria

Inclusion Criteria:

• HIV-1-infected

• Plasma HIV-1 RNA of at least 5,000 copies/mL within 90 days prior to study entry

• HIV genotype (for reverse transcriptase and protease) performed at any time prior to study entry. More information on this criterion can be found in the protocol.

• ARV drug-naive. More information on this criterion can be found in the protocol.

• Negative result from a hepatitis B surface antigen test performed within 90 days prior to study entry

• Agree to use one form of medically-accepted contraceptive throughout the study and for 60 days after stopping study treatment. More information on this criterion can be found in the protocol.

Exclusion Criteria:

• Serious illness requiring systemic treatment and/or hospitalization for at least 7 days prior to study. More information on this criterion can be found in the protocol.

• Screening HIV genotype obtained any time prior to study entry with more than one DRV resistance-associated mutation [RAM] (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, I84V, and L89V) or L76V alone

• Known major integrase inhibitor RAM(s), including N155H, Q148H/R/K, Y143C/R, and G140S

• Severe renal insufficiency requiring hemodialysis or peritoneal dialysis

• Treatment with immunomodulators within 30 days prior to study entry. More information on this criterion can be found in the protocol.

• Current medications that are prohibited with any study medications. More information on this criterion can be found in the protocol.

• Known allergy/sensitivity to study drugs or their formulations. A history of sulfa allergy is not an exclusion.

• Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with the study.

• Certain abnormal laboratory results. More information on this criterion can be found in the protocol.

• Pregnant or breastfeeding