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

This study has been completed.

First Received on November 2, 1999. Last Updated on June 23, 2005 History of Changes

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:	Endpoint Classification: Safety Study Primary Purpose: Treatment
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:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS HIV/AIDS Medicines

Drug Information available for: Zidovudine Lamivudine Indinavir Efavirenz Indinavir Sulfate

U.S. FDA Resources

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

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

Show 41 Study Locations

Sponsors and Collaborators

Dupont Merck

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00002410 History of Changes
Other Study ID Numbers:	281B, DMP 266-006
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:

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

Lamivudine
Indinavir
Genotype
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
Zidovudine
Lamivudine
Reverse Transcriptase Inhibitors

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

ClinicalTrials.gov processed this record on February 12, 2012