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
This study has been completed.
Sponsor:
Merck
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002208
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: February 2003
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Purpose
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 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Stavudine
Sulfate ion
Zidovudine
Lamivudine
Indinavir
Indinavir sulfate
U.S. FDA Resources
Further study details as provided by NIH AIDS Clinical Trials Information Service:
| 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).
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria
Patients must have:
- HIV-1 seropositive status.
- CD4 count greater than 100 cells/mm3.
- Viral RNA above 10,000 copies/mL.
- Consent from parent or guardian if less than 18 years of age.
Exclusion Criteria
Prior Medication:
Excluded:
- Prior therapy with protease inhibitors.
- Prior therapy with 3TC.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002208
Locations
| 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 | |
Sponsors and Collaborators
Merck
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00002208 History of Changes |
| Other Study ID Numbers: | 246M, 069-00 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
|
HIV-1 Drug Therapy, Combination Zidovudine HIV Protease Inhibitors |
Lamivudine Indinavir Reverse Transcriptase Inhibitors |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Zidovudine Stavudine Lamivudine |
Reverse Transcriptase Inhibitors Indinavir HIV Protease Inhibitors Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents Protease Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013