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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Indinavir sulfate

Intervention Type DRUG

Nevirapine

Intervention Type DRUG

Lamivudine

Intervention Type DRUG

Stavudine

Intervention Type DRUG

Didanosine

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Locations

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Cornell AIDS Clinical Trials Unit

New York, New York, United States

Site Status

Countries

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United States

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)

Reference Type BACKGROUND

Norton M. Choosing the right initial antiretroviral regimens. GMHC Treat Issues. 1999 Feb;13(2):7-10.

Reference Type BACKGROUND
PMID: 11366117 (View on PubMed)

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

Other Identifiers

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ATLANTIC STUDY

Identifier Type: -

Identifier Source: org_study_id