A Study of Indinavir Taken With or Without DMP 266

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002393
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:
NIH AIDS Clinical Trials Information Service

Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infections Drug: Indinavir sulfate Drug: Efavirenz Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
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 the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:


  • DMP 266.
  • Other nonnucleoside reverse transcriptase inhibitors.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002393

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

Publications: Identifier: NCT00002393     History of Changes
Other Study ID Numbers: 281A
DMP 266-020
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: July 1998

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination
HIV Protease Inhibitors
Reverse Transcriptase Inhibitors

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers
HIV Protease Inhibitors
Protease Inhibitors
Anti-HIV Agents