Safety and Effectiveness of Giving Indinavir and Nelfinavir to HIV-Infected Patients
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: February 2000
History of Changes
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.
Drug : Indinavir sulfate
Drug : Nelfinavir mesylate
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|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|
Further study details as provided by NIH AIDS Clinical Trials Information Service:
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|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
You may be eligible for this study if you:
- 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.
- Have ever been treated with any protease inhibitors (PIs).
You will not be eligible for this study if you:
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002375
Locations Show More
|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|
Sponsors and CollaboratorsMerck Sharp & Dohme Corp.
|Responsible Party:||Merck Sharp & Dohme Corp.|
|ClinicalTrials.gov Identifier:||NCT00002375 History of Changes|
|Other Study ID Numbers:||246H|
|Study First Received:||November 2, 1999|
|Last Updated:||June 23, 2005|
Keywords provided by NIH AIDS Clinical Trials Information Service:Drug Therapy, Combination
HIV Protease Inhibitors
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on September 16, 2019
This information is provided by ClinicalTrials.gov.