Dual Versus Triple Protease Inhibitor Combinations, Including Ritonavir, in HIV Infected People
A Randomized, Comparative Study of Lopinavir/Ritonavir Versus GW433908 and Ritonavir Versus Lopinavir/Ritonavir and GW433908 (In Combination With Tenofovir Disoproxil Fumarate and One or Two Nucleoside Reverse Transcriptase Inhibitors) in HIV-1-Infected Subjects With Virologic Treatment Failure
6 other identifiers
interventional
56
1 country
13
Brief Summary
Ritonavir (RTV) is a protease inhibitor (PI) commonly used to increase drug levels of other PIs in HIV drug treatment. The purpose of this study is to compare a combination of drugs which includes RTV and 2 protease inhibitors (PIs) with 2 combinations that include RTV and another PI. This study also will compare the effectiveness, safety, tolerability, and drug levels in the blood of these anti-HIV drug combinations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hiv-infections
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 27, 2001
CompletedFirst Posted
Study publicly available on registry
December 28, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2005
CompletedNovember 1, 2021
October 1, 2021
December 27, 2001
October 28, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- HIV infected
- Past anti-HIV therapy consisting of at least 1 PI-containing regimen or detectable viral load, and at least 1 year total anti-HIV therapy experience
- Viral load of more than 5000 copies/ml within 60 days prior to screening while on a stable anti-HIV therapy for at least 12 weeks
- Agree to use acceptable forms of contraception
You may not qualify if:
- More than 7 days of treatment with LPV and/or more than 7 days of treatment with APV or fosamprenavir
- HIV vaccine within 90 days of study entry
- Experimental drugs within 30 days of study entry
- Cancer chemotherapy within 30 days of study entry
- Drugs that affect the immune system within 30 days of study entry
- Certain drugs within 14 days of study entry. Patients who have used drugs that might damage the kidneys within 7 days of study entry are allowed.
- Midazolam within 7 days of study entry
- Allergic or sensitive to study drugs
- Excessive drug or alcohol use
- Serious illness requiring treatment and/or hospitalization and have not completed therapy, or are not stable on therapy for at least 14 days prior to study entry
- Pregnant or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
USC CRS
Los Angeles, California, 90033-1079, United States
Ucsf Aids Crs
San Francisco, California, 94110, United States
The Ponce de Leon Ctr. CRS
Atlanta, Georgia, 30308, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, 462025250, United States
Indiana Univ. School of Medicine, Wishard Memorial
Indianapolis, Indiana, 46202, United States
Methodist Hosp. of Indiana
Indianapolis, Indiana, 46202, United States
HIV Prevention & Treatment CRS
New York, New York, United States
Univ. of Cincinnati CRS
Cincinnati, Ohio, 452670405, United States
Case CRS
Cleveland, Ohio, 44106, United States
MetroHealth CRS
Cleveland, Ohio, 441091998, United States
The Ohio State Univ. AIDS CRS
Columbus, Ohio, 432101228, United States
Vanderbilt Therapeutics CRS
Nashville, Tennessee, 37203, United States
University of Washington AIDS CRS
Seattle, Washington, 98104, United States
Related Publications (6)
Cooper CL, van Heeswijk RP, Gallicano K, Cameron DW. A review of low-dose ritonavir in protease inhibitor combination therapy. Clin Infect Dis. 2003 Jun 15;36(12):1585-92. doi: 10.1086/375233. Epub 2003 Jun 5.
PMID: 12802760BACKGROUNDCvetkovic RS, Goa KL. Lopinavir/ritonavir: a review of its use in the management of HIV infection. Drugs. 2003;63(8):769-802. doi: 10.2165/00003495-200363080-00004.
PMID: 12662125BACKGROUNDMoyle GJ, Back D. Principles and practice of HIV-protease inhibitor pharmacoenhancement. HIV Med. 2001 Apr;2(2):105-13. doi: 10.1046/j.1468-1293.2001.00063.x.
PMID: 11737387BACKGROUNDNadler J. New anti-HIV protease inhibitors provide more treatment options. AIDS Patient Care STDS. 2003 Nov;17(11):551-64. doi: 10.1089/108729103322555944.
PMID: 14746663BACKGROUNDvan Heeswijk RP, Veldkamp A, Mulder JW, Meenhorst PL, Lange JM, Beijnen JH, Hoetelmans RM. Combination of protease inhibitors for the treatment of HIV-1-infected patients: a review of pharmacokinetics and clinical experience. Antivir Ther. 2001 Dec;6(4):201-29.
PMID: 11878403BACKGROUNDKashuba AD, Tierney C, Downey GF, Acosta EP, Vergis EN, Klingman K, Mellors JW, Eshleman SH, Scott TR, Collier AC. Combining fosamprenavir with lopinavir/ritonavir substantially reduces amprenavir and lopinavir exposure: ACTG protocol A5143 results. AIDS. 2005 Jan 28;19(2):145-52. doi: 10.1097/00002030-200501280-00006.
PMID: 15668539RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ann C. Collier, MD
University of Washington
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 27, 2001
First Posted
December 28, 2001
Study Completion
July 1, 2005
Last Updated
November 1, 2021
Record last verified: 2021-10