A Study of Three Drug Combination Therapies in HIV-Infected Patients Who Have Never Been Treated With Anti-HIV Drugs - Full Text View

Sponsored by:	Weill Medical College of Cornell University
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002407

Purpose

The purpose of this study is to see if it is safe and effective to give one of three different triple-drug combinations to HIV-infected patients who have never been treated with anti-HIV drugs.

Condition	Intervention
HIV Infections	Drug: Indinavir sulfate Drug: Nevirapine Drug: Lamivudine Drug: Stavudine Drug: Didanosine

MedlinePlus related topics: AIDS AIDS Medicines

Drug Information available for: Lamivudine Indinavir Indinavir Sulfate Didanosine Stavudine Nevirapine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Efficacy Study
Official Title:	A Randomized Open-Label Strategic Study to Evaluate the Safety and Efficacy of 3 Different Convergent and Divergent Drug Combination Therapies in Anti-Retroviral Naive HIV-1 Infected Patients With CD4+ Counts Above 200/mm3

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

Detailed Description:

In this open-label, strategic study patients are evaluated at Weeks 0, 1, 2, 4, 8, 12 to Week 48 after being treated on one of the following regimens:

Stavudine (d4T) + Didanosine (ddI) + Lamivudine (3TC) or d4T + ddI + Indinavir or d4T + ddI + Nevirapine.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Patients must have:

Diagnosed asymptomatic HIV infection.
HIV-1 RNA greater than 500 copies/ml.
CD4+ T-cell count greater than 200/mm3.
Never received antiretroviral therapy.

Exclusion Criteria

Co-existing Condition:

Excluded:

Severe non-HIV-related disease.

Patients with the following prior conditions are excluded:

History of neuropathy.

Prior Medication:

Excluded:

Investigational drug within 1 month prior to study.
Immunomodulatory drug within 1 month prior to study.

Prior Treatment:

Excluded:

Radiation therapy within past month.
Chemotherapy within past month.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002407

Locations

United States, New York
Cornell AIDS Clinical Trials Unit
New York, New York, United States, 10021

Sponsors and Collaborators

Weill Medical College of Cornell University

More Information

Publications:

Katlama C, Murphy R, Johnson V, Squires K, Horban A, Gatell J, Clotet B, Staszewski S, VanLeeuwen R, Clumeck N, Moroni M, Pavia A, Schmidt Au Gonzalez-Lahoz J, Antunes F, Gulick R, Banhegyi D, Montaner J, Calvez V, Sommadossi JP, Lange J. The Atlantic study: a randomised open-label study comparing two protease inhibitors (PI)-sparing antiretroviral strategies versus a standard PI-containing regimen. Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4;6th:70 (abstract no 18)

Norton M. Choosing the right initial antiretroviral regimens. GMHC Treat Issues. 1999 Feb;13(2):7-10. No abstract available.

Murphy RL, Katlama C, Weverling GJ, et al. Fat redistribution and metabolic changes with a nucleoside-reverse transcriptase inhibitor (NRTI), non-NRTI, or protease inhibitor-based regimen: FRAMS substudy of the Atlantic study. Program and abstracts of the XIV International AIDS Conference; July 7-12, 2002; Barcelona, Spain. Abstract WeOrB1306.

Study ID Numbers:	ATLANTIC STUDY
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002407
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Virus Diseases
Nevirapine
Sexually Transmitted Diseases, Viral
Stavudine
Didanosine
Indinavir

HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lamivudine
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 January 14, 2009