A Study of Three Drug Combination Therapies in HIV-Infected Patients Who Have Never Been Treated With Anti-HIV Drugs
This study has been completed.
Sponsor:
Weill Medical College of Cornell University
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002407
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: November 1998
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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:
Further study details as provided by NIH AIDS Clinical Trials Information Service:
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
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
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)
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 |
ClinicalTrials.gov processed this record on February 27, 2015