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

Completed · Phase 2

Conditions studied: HIV-1 Infections

In brief

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.

Key facts

Study ID

NCT00830804

Run by

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

People needed

113

Starts

2009-04-01

Expected to finish

2010-09-01

Last updated by the study team

2018-11-08

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• AlabamaTherapeutics CRS — Birmingham, Alabama, United States
• Stanford CRS — Palo Alto, California, United States
• Ucsd, Avrc Crs — San Diego, California, United States
• Ucsf Aids Crs — San Francisco, California, United States
• University of Colorado Hospital CRS — Aurora, Colorado, United States
• Georgetown University CRS — Washington D.C., District of Columbia, United States
• Northwestern University CRS — Chicago, Illinois, United States
• Beth Israel Deaconess Med Center — Boston, Massachusetts, United States
• Brigham and Women's Hosp. ACTG CRS — Boston, Massachusetts, United States
• Washington U CRS — St Louis, Missouri, United States
• AIDS Community Health Ctr. ACTG CRS — Rochester, New York, United States
• Unc Aids Crs — Chapel Hill, North Carolina, United States
• Duke Univ. Med. Ctr. Adult CRS — Durham, North Carolina, United States
• Univ. of Cincinnati CRS — Cincinnati, Ohio, United States
• Case CRS — Cleveland, Ohio, United States
• MetroHealth CRS — Cleveland, Ohio, United States
• The Ohio State Univ. AIDS CRS — Columbus, Ohio, United States
• Hosp. of the Univ. of Pennsylvania CRS — Philadelphia, Pennsylvania, United States
• University of Pittsburgh CTU — Pittsburgh, Pennsylvania, United States
• The Miriam Hospital — Providence, Rhode Island, United States
• Vanderbilt Therapeutics CRS — Nashville, Tennessee, United States
• Houston AIDS Research Team — Houston, Texas, United States

Full record on ClinicalTrials.gov

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