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

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Status and phase

Completed

Phase 2

Conditions

HIV-1 Infections

Treatments

Drug: Raltegravir

Drug: Darunavir/Ritonavir

Study type

Interventional

Funder types

NETWORK

NIH

Identifiers

NCT00830804

1U01AI068636 (U.S. NIH Grant/Contract)

ACTG A5262

Details and patient eligibility

About

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.

Full description

Despite the remarkable strides made in the treatment of HIV-1-infected persons over the last decade, current first-line ART regimens are imperfect. The ideal combination, unlike some current first-line options, would have uncompromised efficacy in the presence of transmitted drug-resistant variants. The primary purpose of this study is to estimate the cumulative proportion of ART-naive participants experiencing virologic failure at or prior to week 24 after initiating raltegravir (RAL) plus darunavir/ritonavir (DRV/RTV).

The study will last 52 weeks. All participants will follow the same treatment schedule and take RAL plus DRV/RTV orally daily for the duration of the trial.

After entry, all participants will have scheduled visits at weeks 1, 4, 12, 24, 36, 48, and 52. Medical/medication history, blood and urine collection, and liver function tests will occur at screening. A targeted physical exam and concomitant medications history will occur at all study visits. Blood and urine collection and liver function tests will occur at most study visits. For females, a pregnancy test will occur at screening and study entry.

RAL and DRV were provided by the study. RTV was not provided by the study.

Enrollment

113 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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