A Study of Three Different Anti-HIV Drug Combinations in HIV-Infected Patients - Full Text View

Sponsor:	Dupont Merck
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002410

Purpose

The purpose of this study is to compare the safety and effectiveness of three anti-HIV drug combinations. The three combinations are: (1) efavirenz (DMP 266) plus indinavir; (2) DMP 266 plus zidovudine (ZDV) plus lamivudine (3TC); and (3) indinavir plus ZDV plus 3TC. This study also examines the resistance HIV may have to these drugs and if these drugs are effective over a long period of time.

Condition	Intervention	Phase
HIV Infections	Drug: Indinavir sulfate Drug: Lamivudine Drug: Zidovudine	Phase III

Study Type:	Interventional
Study Design:	Treatment, Safety Study
Official Title:	A Phase III, Multicenter, Randomized, Open-Label Study to Compare Antiretroviral Activity and Tolerability of Three Different Combination Regimens (DMP 266 + Indinavir, DMP 266 + Zidovudine + Lamivudine, Indinavir + Zidovudine + Lamivudine) in HIV-Infected Patients

Resource links provided by NLM:

MedlinePlus related topics: AIDS AIDS Medicines

Drug Information available for: Zidovudine Lamivudine Indinavir Efavirenz Indinavir Sulfate

U.S. FDA Resources

Eligibility

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

Criteria

Exclusion Criteria

Concurrent Medication:

Excluded:

Terfenadine, astemizole, cisapride, triazolam, or midazolam (competition for the enzyme cytochrome P-450 3A4 [CYP3A4] by indinavir could result in inhibition of metabolic breakdown of these drugs and create the potential for serious and/or life threatening events [i.e., cardiac arrhythmia, prolonged sedation]).
Rifampin or rifabutin (prohibited because of potential drug interaction with indinavir).
Ketoconazole, itraconazole, and clarithromycin.
Concomitant systemic therapy for acute opportunistic infection or malignancy.

Excluded:

Life expectancy less than 12 months.

Prior Medication:

Excluded:

Prior treatment with efavirenz, 3TC, an NNRTI, or an HIV protease inhibitor.
Prior antiretroviral agent within 14 days of initiating study treatment.
Prior treatment (within 30 days of initiating study treatment) with any other experimental drug for any indication.

Patients must:

Have a diagnosis of HIV infection.
Have CD4 counts greater than or equal to 50 cell/mm3.
Have a life expectancy greater than or equal to 12 months.
Be post-pubescent.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002410

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Locations

United States, Arizona
Phoenix Body Positive
Phoenix, Arizona, United States, 85016
Arizona Clinical Research Ctr Inc
Tucson, Arizona, United States, 85712
United States, California
Paul Cimoch
Irvine, California, United States, 92618
Richard Stryker
Beverly Hills, California, United States, 90210
AIDS Healthcare Foundation
Los Angeles, California, United States, 90027
Oasis Clinic / Martin Luther Jr Gen Hosp / King-Drew Med Ctr
Los Angeles, California, United States, 90059
Kraus Med Group
Los Angeles, California, United States, 90036
United States, Connecticut
Blick Med Associates
Stamford, Connecticut, United States, 06901
United States, District of Columbia
Novum Inc
Washington, District of Columbia, United States, 20037
United States, Florida
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, United States, 32960
Infectious Disease Research Institute
Tampa, Florida, United States, 33614
Bach and Godofsky
Bradenton, Florida, United States, 34205
Boulevard Comprehensive Care Ctr
Jacksonville, Florida, United States, 32209
Daniel Seekins
Tampa, Florida, United States, 33614
Ctr for Quality Care
Tampa, Florida, United States, 33609
Larry Marc Bush / c/o Sally Yantis
Lake Worth, Florida, United States, 33463
Univ of Miami School of Medicine
Miami, Florida, United States, 33136
Community Research Initiative of South Florida
Coral Gables, Florida, United States, 33146
United States, Georgia
Med College of Georgia
Augusta, Georgia, United States, 30912
Georgia Research Associates
Atlanta, Georgia, United States, 30342
United States, Indiana
Infectious Diseases
Indianapolis, Indiana, United States, 46202
United States, Kentucky
Univ of Kentucky Med Ctr
Lexington, Kentucky, United States, 40536
United States, Missouri
Kansas City AIDS Research Consortium
Kansas City, Missouri, United States, 64111
United States, Nebraska
Univ of Nebraska Med Ctr / HIV Clinic
Omaha, Nebraska, United States, 681985400
United States, Nevada
Univ Med Ctr / HIV Wellness Ctr
Las Vegas, Nevada, United States, 89102
United States, New York
Community Research Initiative on AIDS
New York, New York, United States, 10001
Clinical Directors Network / HIV/AIDS Program Manager
New York, New York, United States, 10011
United States, North Carolina
Wake Forest Univ School of Medicine
Winston Salem, North Carolina, United States, 27157
United States, Ohio
Remington-Davis Inc
Columbus, Ohio, United States, 43215
United States, Pennsylvania
Philadelphia FIGHT
Philadelphia, Pennsylvania, United States, 19107
United States, Rhode Island
The Miriam Hosp
Providence, Rhode Island, United States, 02906
United States, Texas
Division of Infectious Disease / Dept of Internal Medicine
Dallas, Texas, United States, 752359113
UT-Health Science Ctr
Houston, Texas, United States, 77030
Diagnostic Clinic of San Antonio
San Antonio, Texas, United States, 78229
Montrose Clinic
Houston, Texas, United States, 77006
Research Services 2000 Inc
Fort Worth, Texas, United States, 76103
Research Services 2000 Inc
Dallas, Texas, United States, 75208
United States, Virginia
Oyster Point Med Specialists
Newport News, Virginia, United States, 23606
United States, Washington
Novum Inc / Pharmaceutical Research Services
Seattle, Washington, United States, 98122
United States, Wisconsin
Infectious Diseases Associates
Milwaukee, Wisconsin, United States, 53215
Puerto Rico
Javier O Morales Ramirez
San Juan, Puerto Rico, 00909

Sponsors and Collaborators

Dupont Merck

More Information

No publications provided

Study ID Numbers:	281B, DMP 266-006
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002410 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

HIV-1
Drug Therapy, Combination
Zidovudine
Drug Resistance, Microbial
HIV Protease Inhibitors

Lamivudine
Indinavir
Genotype
Reverse Transcriptase Inhibitors
efavirenz

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Indinavir
Molecular Mechanisms of Pharmacological Action
Zidovudine
Lamivudine
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors

HIV Protease Inhibitors
RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Protease Inhibitors
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on November 22, 2009