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

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

MedlinePlus related topics:

AIDS AIDS Medicines

Drug Information available for:

Zidovudine Lamivudine Indinavir Indinavir Sulfate Efavirenz

U.S. FDA Resources

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

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

Study ID Numbers:	281B, DMP 266-006
First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002410
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

Study placed in the following topic categories:

Virus Diseases

Efavirenz

Sexually Transmitted Diseases, Viral

Indinavir

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Lamivudine

Zidovudine

Retroviridae Infections

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Antimetabolites

Anti-Infective Agents

HIV Protease Inhibitors

RNA Virus Infections

Anti-HIV Agents

Slow Virus Diseases

Immune System Diseases

Molecular Mechanisms of Pharmacological Action

Enzyme Inhibitors

Infection

Antiviral Agents

Pharmacologic Actions

Protease Inhibitors

Reverse Transcriptase 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:	NCT00002410