Status:
COMPLETED
Safety and Effectiveness of Raltegravir Plus Darunavir/Ritonavir in Treatment-Naive HIV-Infected Adults
Lead Sponsor:
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV-1 Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed 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-lin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT00830804
Start Date
April 1 2009
End Date
September 1 2010
Last Update
November 8 2018
Active Locations (22)
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1
AlabamaTherapeutics CRS
Birmingham, Alabama, United States, 35294
2
Stanford CRS
Palo Alto, California, United States, 94304
3
Ucsd, Avrc Crs
San Diego, California, United States, 92103
4
Ucsf Aids Crs
San Francisco, California, United States, 94110