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A Study of Three Drug Combination Therapies in HIV-Infected Patients Who Have Never Been Treated with Anti-HIV Drugs



A Study of Three Drug Combination Therapies in HIV-Infected Patients Who Have Never Been Treated with Anti-HIV Drugs

For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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:
Study Type:  Interventional, Treatment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 

Location and Contact Information:

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


Additional Information:
Study ID Numbers:  ATLANTIC STUDY; 
Study Start Date: 
Record last reviewed: November 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002407

Other Hiv Infections Studies:
1. The Safety and Effectiveness of Pentamidine in the Prevention of Pneumocystis carinii Pneumonia (PCP) in Patients with AIDS Who Have Had PCP Before

2. A Double-Blind, Placebo-Controlled Trial of Albendazole in HIV-positive Patients with Intestinal Microsporidiosis

3. A Study of Zidovudine Plus Acyclovir in HIV-Infected Patients

4. Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis

5. Safety and Effectiveness of Adding Adefovir Dipivoxil and Nelfinavir to the Anti-HIV Therapy of HIV-Infected Children

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