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

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
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 December 03, 2008

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