Safety and Effectiveness of Giving Indinavir and Nelfinavir to HIV-Infected Patients
NCT ID: NCT00002375
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
Brief Summary
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It is thought that IDV plus NFV will be a safe drug combination for treating HIV.
Detailed Description
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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.
Conditions
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Study Design
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PARALLEL
TREATMENT
Interventions
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Indinavir sulfate
Nelfinavir mesylate
Eligibility Criteria
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Inclusion Criteria
* Are HIV-positive.
* Have a CD4 count of at least 100 cells/mm3.
* Have a plasma viral load (level of HIV in the blood) of at least 30,000 copies/ml.
* Are at least 18 years old.
Exclusion Criteria
* Have ever been treated with any protease inhibitors (PIs).
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Locations
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Univ of Alabama at Birmingham
Birmingham, Alabama, United States
UCSD Treatment Ctr / Dept of Medicine and Pediatrics
San Diego, California, United States
Univ of Pittsburgh / Graduate School of Public Health
Pittsburgh, Pennsylvania, United States
Countries
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Other Identifiers
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MK-0639
Identifier Type: -
Identifier Source: secondary_id
061-00
Identifier Type: -
Identifier Source: secondary_id
246H
Identifier Type: -
Identifier Source: org_study_id