A Study of Indinavir Taken With or Without DMP 266

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002393
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: July 1998
  Purpose

The purpose of this study is to see if it is safe and effective to add DMP 266 to an anti-HIV treatment program of indinavir and nucleoside reverse transcriptase inhibitors (NRTIs).


Condition Intervention Phase
HIV Infections
Drug: Indinavir sulfate
Drug: Efavirenz
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: A Phase III, Double-Blind, Placebo-Controlled, Multicenter Study to Determine the Effectiveness and Tolerability of the Combination of DMP 266 and Indinavir Versus Indinavir in HIV-Infected Patients Receiving Nucleoside Analogue (NRTI) Therapy

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 300
Detailed Description:

In this double-blind, placebo-controlled study, 300 patients are randomized to 1 or 2 reverse transcriptase inhibitors of their choice plus blinded therapy on Arm A or B as follows:

Arm A: DMP 266 placebo plus indinavir. Arm B: DMP 266 plus indinavir. After 16 weeks, patients may switch the NRTI portion of their regimen if they meet a treatment failure criterion. After the completion of the 24-week period, patients have the option to continue on open-label DMP 266 and indinavir.

  Eligibility

Ages Eligible for Study:   13 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Patients must have:

  • CD4+ cell count of at least 50 cells/mm3.
  • HIV RNA level of at least 10,000 copies/ml by reverse transcriptase polymerase chain reaction (RT-PCR, Amplicor test kit) at screening.
  • Signed, informed consent from parent or legal guardian for patients less than 18 years of age.

Exclusion Criteria

Prior Medication:

Excluded:

  • DMP 266.
  • Other nonnucleoside reverse transcriptase inhibitors.

Required:

One or two NRTIs (except ZDV and d4T in combination) for a minimum of 8 weeks, within 12 weeks prior to screening.

  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: NCT00002393

Locations
United States, California
Kaiser Foundation Hospital
San Francisco, California, United States, 94118
United States, Georgia
Med College of Georgia
Augusta, Georgia, United States, 30912
United States, Illinois
Chicago Ctr for Clinical Research
Chicago, Illinois, United States, 60610
United States, Kentucky
Univ of Kentucky Med Ctr / Chandler Med Ctr
Lexington, Kentucky, United States, 405360084
United States, Louisiana
Tulane Univ / Tulane / LSU Clinical Trials Unit
New Orleans, Louisiana, United States, 70122
United States, New York
Mount Sinai Med Ctr
New York, New York, United States, 10029
Univ of Rochester Med Ctr
Rochester, New York, United States, 14642
United States, Tennessee
Vanderbilt Univ
Nashville, Tennessee, United States, 372321302
United States, Virginia
Hampton Roads Med Specialists
Hampton, Virginia, United States, 23666
Canada, Alberta
Southern Alberta HIV Clinic / Foot Hills Hosp
Calgary, Alberta, Canada
Canada, Ontario
Ottawa Gen Hosp
Ottawa, Ontario, Canada
Puerto Rico
Univ of Puerto Rico School of Medicine
San Juan, Puerto Rico, 00927
Sponsors and Collaborators
Dupont Merck
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00002393     History of Changes
Other Study ID Numbers: 281A, DMP 266-020
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:
Placebos
Drug Therapy, Combination
HIV Protease Inhibitors
Indinavir
Reverse Transcriptase Inhibitors
efavirenz

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
HIV Protease Inhibitors
Indinavir
Efavirenz
Reverse Transcriptase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on July 22, 2014