Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Merck |
---|---|
Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002208 |
To demonstrate that the antiviral activity and safety/tolerability of a test regimen of indinavir is equivalent to that of a control regimen of indinavir when each is coadministered with zidovudine (ZDV) (or stavudine, d4T) and lamivudine (3TC) for 24 weeks to protease inhibitor- and 3TC-naive HIV-1-seropositive patients. To characterize the steady-state pharmacokinetic profiles of indinavir, ZDV (or d4T), and 3TC in the presence of each other, for both the control and test regimen groups.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: Indinavir sulfate Drug: Lamivudine Drug: Stavudine Drug: Zidovudine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Pharmacokinetics Study |
Official Title: | A Multicenter, Open-Label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate, 800 Mg q 8 h Versus 1,200 Mg q 12 h in Combination With Zidovudine and 3TC |
Estimated Enrollment: | 400 |
Patients are randomized to 1 of 2 arms:
Arm A: Indinavir plus ZDV plus 3TC. Arm B: Indinavir (test dose) plus ZDV plus 3TC. NOTE: d4T may be substituted for zidovudine for toxicity management. Patients are stratified based on prior use of nucleoside analogs (naive vs experienced to ZDV, dideoxyinosine [ddI], dideoxycytidine [ddC], and d4T) and screening viral RNA results (lower than 50,000 copies/mL vs more than 50,000 copies/mL).
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Prior Medication:
Excluded:
United States, Alabama | |
Univ of Alabama at Birmingham | |
Birmingham, Alabama, United States, 352942050 | |
United States, California | |
LAC/USC Med Ctr | |
Los Angeles, California, United States, 90033 | |
Kaiser Med Ctr | |
San Francisco, California, United States, 94110 | |
United States, Delaware | |
Wilmington Hosp / Med Ctr of Delaware | |
Wilmington, Delaware, United States, 19899 | |
United States, District of Columbia | |
Georgetown Univ Med Ctr | |
Washington, District of Columbia, United States, 20007 | |
United States, Georgia | |
AIDS Research Consortium of Atlanta | |
Atlanta, Georgia, United States, 30308 | |
United States, Illinois | |
Cook County Hosp | |
Chicago, Illinois, United States, 60612 | |
United States, Maryland | |
Johns Hopkins Hosp | |
Baltimore, Maryland, United States, 21287 | |
United States, Missouri | |
Washington Univ | |
St. Louis, Missouri, United States, 63108 | |
United States, New York | |
Univ Hosp / SUNY at Stony Brook / AIDS TMT Unit | |
Stony Brook, New York, United States, 117948153 | |
United States, Pennsylvania | |
Allegheny Univ Hosp | |
Philadelphia, Pennsylvania, United States, 19129 | |
Pittsburgh Treatment Ctr / Univ of Pittsburgh | |
Pittsburgh, Pennsylvania, United States, 15261 | |
United States, Rhode Island | |
Brown Univ / Miriam Hosp | |
Providence, Rhode Island, United States, 02906 | |
United States, Tennessee | |
Vanderbilt Univ Med Ctr | |
Nashville, Tennessee, United States, 372321302 | |
United States, Washington | |
Univ of Washington / AIDS Clinical Trial Unit | |
Seattle, Washington, United States, 98104 |
Study ID Numbers: | 246M, 069-00 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002208 |
Health Authority: | United States: Food and Drug Administration |
HIV-1 Drug Therapy, Combination Zidovudine HIV Protease Inhibitors |
Lamivudine Indinavir Reverse Transcriptase Inhibitors |
Virus Diseases Sexually Transmitted Diseases, Viral Stavudine Indinavir HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Lamivudine Zidovudine Retroviridae Infections Immunologic Deficiency Syndromes |
Antimetabolites Anti-Infective Agents HIV Protease Inhibitors RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Protease Inhibitors Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |