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Home > "A" Clinical Trials Conditions > A Comparison of Epivir Plus Crixivan Combined with Zerit or Retrovir in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

A Comparison of Epivir Plus Crixivan Combined with Zerit or Retrovir in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs



A Comparison of Epivir Plus Crixivan Combined with Zerit or Retrovir in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): Bristol-Myers Squibb ,
Synopsis: To evaluate the tolerance, and comparative virologic and immunologic effects of the two combination regimens.
Details: 100 patients will be randomized to receive Zerit (Stavudine) + Epivir (Lamivudine) + Crixivan (Indinavir) and 100 patients will be randomized to receive Retrovir (Zidovudine) + Epivir (Lamivudine) + Crixivan (Indinavir). Patients will be treated for 48 weeks.
Eligibility:
Study Type:
  Interventional, Treatment, Parallel Assignment, Safety Study
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - Documented HIV infection. - CD4 cell count of 200 - 700 cells/mm3. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: AIDS defining condition within 1 month of study entry. Prior Medication: Excluded: Patients with any history of antiretroviral therapy treatment.
Total Enrollment: 200

Location and Contact Information:

Advance Clinical Research
Atlanta,  Georgia,  30327
United States
 

HIV Clinical Research Ctr
Ft. Lauderdale,  Florida,  33316
United States
 

Boston Univ Med Ctr Hosp / Evans - 556
Boston,  Massachusetts,  02118
United States
 

Univ of Alabama at Birmingham
Birmingham,  Alabama,  35294
United States
 

Washington Univ School of Medicine
St. Louis,  Missouri,  63108
United States
 

Blackstock Family Health Ctr
Austin,  Texas,  76751
United States
 

Hosp Regional de Ponce - Area Vieja
Ponce,  ,  00731
Puerto Rico
 

Community Research Initiative of New England
Brookline,  Massachusetts,  02445
United States
 

San Juan AIDS Program
Santurce,  ,  00908
Puerto Rico
 

Louisiana State Univ Med Ctr / HIV Outpatient Clinic
New Orleans,  Louisiana,  70112
United States
 

Infectious Disease Research Institute Inc
Tampa,  Florida,  33614
United States
 


Additional Information:
Study ID Numbers:
  260A;  BMS 001
Study Start Date: 
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002369

Other Hiv Infections Studies:
1. Comparison of Two Drugs, Cidofovir and Ganciclovir, in Treating Patients with AIDS Who Have CMV Retinitis

2. Comparison of Three Different Initial Treatments, Not Using Protease Inhibitors, for HIV Infection

3. A Phase I Safety, Efficacy, and Pharmacokinetic Study of 2',3'-Dideoxyinosine (ddI) Administered Twice Daily to Patients With AIDS or AIDS Related Complex

4. A Study of Dideoxycytidine in HIV-Infected Patients

5. Phase I Study of the Clinical Pharmacology of Azithromycin in Buffy Coat of HIV-Infected Subjects.

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A Comparison of Epivir Plus Crixivan Combined with Zerit or Retrovir in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

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