A Study of Indinavir Taken With or Without DMP 266 - Full Text View

Sponsored by:	Dupont Merck
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002393

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 III

MedlinePlus related topics: AIDS

Drug Information available for: Indinavir Indinavir Sulfate Efavirenz

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Parallel Assignment, Efficacy Study
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

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

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:

Haas DW, Fessel WJ, Delapenha RA, Kessler H, Seekins D, Kaplan M, Ruiz NM, Ploughman LM, Labriola DF, Manion DJ. Therapy with efavirenz plus indinavir in patients with extensive prior nucleoside reverse-transcriptase inhibitor experience: a randomized, double-blind, placebo-controlled trial. J Infect Dis. 2001 Feb 1;183(3):392-400.

Study ID Numbers:	281A, DMP 266-020
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002393
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

Study placed in the following topic categories:

Virus Diseases
Efavirenz
Sexually Transmitted Diseases, Viral
Indinavir
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
HIV Protease Inhibitors
Slow Virus Diseases
Anti-HIV Agents
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection

Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Protease Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 14, 2009