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

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


Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS HIV/AIDS Medicines

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

U.S. FDA Resources

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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.

Douglas J. Ward, MD. Lipodystrophy Substudy of Atlantic Trial Offers Limited Insights. http://www.medscape.com/viewarticle/438301

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.


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

Additional relevant MeSH terms:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Lamivudine Nevirapine Stavudine Didanosine Indinavir	Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents Cytochrome P-450 CYP3A Inducers Cytochrome P-450 Enzyme Inducers HIV Protease Inhibitors Protease Inhibitors Antimetabolites

ClinicalTrials.gov processed this record on September 26, 2016