Clinical Trials

MainTitle

Safety and Effectiveness of Giving Indinavir and Nelfinavir to HIV-Infected Patients

This study has been completed
Sponsor
Merck Sharp & Dohme Corp.


Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier
NCT00002375

First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: February 2000
History of Changes
Purpose

Purpose

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
HIV Infections

Drug : Indinavir sulfate
Drug : Nelfinavir mesylate

Study Type: Interventional
Study Design: 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:

Enrollment: 24

Detailed Description:

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria
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.

  • Exclusion Criteria
    You will not be eligible for this study if you:
  • Have ever been treated with any protease inhibitors (PIs).

contacts and locations

Contacts and Locations

Choosing 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

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 Collaborators

Merck Sharp & Dohme Corp.
More Information

More Information


Responsible Party: Merck Sharp & Dohme Corp.  
ClinicalTrials.gov Identifier: NCT00002375   History of Changes  
Other Study ID Numbers: 246H  
  MK-0639  
  061-00  
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
Indinavir
Nelfinavir
Anti-HIV Agents

Additional relevant MeSH terms:
HIV Infections
Nelfinavir
Indinavir

ClinicalTrials.gov processed this data on December 08, 2017
This information is provided by ClinicalTrials.gov.