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Sponsored by: |
Merck |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002375 |
The purpose of this study is to see if it is safe and effective to treat HIV-infected patients with indinavir (IDV) plus nelfinavir (NFV), 2 anti-HIV medications. It is thought that IDV plus NFV will be a safe drug combination for treating HIV.
Condition | Intervention |
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HIV Infections |
Drug: Indinavir sulfate Drug: Nelfinavir mesylate |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Safety Study |
Official Title: | A Multicenter, 24-Week Study of the Safety, Pharmacokinetics, and Activity of the Coadministration of Indinavir and Nelfinavir in HIV-1 Seropositive Patients |
Estimated Enrollment: | 24 |
It is hypothesized that the administration of indinavir with nelfinavir will be generally safe and well tolerated.
This is a parallel, time-lagged, 2-stage, multiple-dose, 24-week study in HIV-1 seropositive patients. In the 3-week, randomized, double-blind phase of Stage A, patients receive either indinavir plus nelfinavir (Group A1: 9 patients) or indinavir placebo plus nelfinavir placebo (Group A2: 3 patients) for the first week. In Week 2, patients in Group A1 have the nelfinavir dose increased. This dose escalation for nelfinavir is contingent upon the patient having completed 1 week of the study drugs without experiencing Grade 3 or worse toxicity and/or serious drug-related adverse events. Patients in Group A2 continue to receive placebo until Week 3, at which time they receive indinavir plus nelfinavir (initial dose), while patients in Group A1 continue with indinavir plus nelfinavir (escalated dose). At Week 4 all patients in Stage A (including those originally assigned to receive placebo) receive open-label indinavir plus nelfinavir (escalated dose) for the remainder of the 24 weeks. After at least 6 patients in Stage A have completed at least 2 weeks of therapy with nelfinavir plus indinavir with acceptable tolerability, Stage B begins. In the 2-week, randomized, double-blind phase of Stage B, patients receive either indinavir plus nelfinavir (Group B1: 9 patients) or indinavir placebo plus nelfinavir placebo (Group B2, 3 patients). After 2 weeks, all patients in Stage B (including those originally assigned to receive placebo) receive open-label indinavir plus nelfinavir for the remainder of the 24 weeks.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
You may be eligible for this study if you:
Exclusion Criteria
You will not be eligible for this study if you:
United States, Alabama | |
Univ of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294 | |
United States, California | |
UCSD Treatment Ctr / Dept of Medicine and Pediatrics | |
San Diego, California, United States, 92103 | |
United States, Pennsylvania | |
Univ of Pittsburgh / Graduate School of Public Health | |
Pittsburgh, Pennsylvania, United States, 15261 |
Study ID Numbers: | 246H, MK-0639, 061-00 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002375 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Drug Therapy, Combination HIV Protease Inhibitors Indinavir Nelfinavir Anti-HIV Agents |
Anti-Infective Agents Sexually Transmitted Diseases, Viral HIV Protease Inhibitors Anti-HIV Agents Indinavir Acquired Immunodeficiency Syndrome Antiviral Agents Immunologic Deficiency Syndromes |
Protease Inhibitors Virus Diseases Anti-Retroviral Agents HIV Infections Sexually Transmitted Diseases Nelfinavir Retroviridae Infections |
Anti-Infective Agents HIV Protease Inhibitors RNA Virus Infections Sexually Transmitted Diseases, Viral Anti-HIV Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Indinavir Acquired Immunodeficiency Syndrome Enzyme Inhibitors Infection |
Antiviral Agents Pharmacologic Actions Immunologic Deficiency Syndromes Protease Inhibitors Virus Diseases Anti-Retroviral Agents HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Nelfinavir Retroviridae Infections |