A Study of Three Drug Combination Therapies in HIV-Infected Patients Who Have Never Been Treated With Anti-HIV Drugs
NCT ID: NCT00002407
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
INTERVENTIONAL
Brief Summary
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Detailed Description
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Stavudine (d4T) + Didanosine (ddI) + Lamivudine (3TC) or d4T + ddI + Indinavir or d4T + ddI + Nevirapine.
Conditions
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Study Design
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TREATMENT
Interventions
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Indinavir sulfate
Nevirapine
Lamivudine
Stavudine
Didanosine
Eligibility Criteria
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Inclusion Criteria
* 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
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.
18 Years
ALL
No
Sponsors
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Weill Medical College of Cornell University
OTHER
Locations
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Cornell AIDS Clinical Trials Unit
New York, New York, United States
Countries
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References
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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.
Other Identifiers
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ATLANTIC STUDY
Identifier Type: -
Identifier Source: org_study_id