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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00002369
• Date of registration: 02/11/1999
• Primary sponsor: Bristol-Myers Squibb
• Public title: A Comparison of Epivir Plus Crixivan Combined With Zerit or Retrovir in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
• Scientific title: An Open Label, Randomized, Comparative Study of Zerit (d4T) + Epivir (3TC) + Crixivan Versus Retrovir (AZT) + Epivir (3TC) + Crixivan in HIV-Infected, Antiretroviral Naive Subjects With CD4 Cell Counts of 200 - 700 Cells/mm3 and HIV RNA Baseline Copy Number of >= 10,000 Copies/ml
• Date of first enrolment: August 1999
• Target sample size: 200
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00002369
• Study type: Interventional
• Study design: Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Countries of recruitment

Puerto Rico, United States

Key inclusion & exclusion 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.



Age minimum: 16 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

HIV Infections

Intervention(s)

Drug: Indinavir sulfate

Drug: Lamivudine

Drug: Stavudine

Drug: Zidovudine

Secondary ID(s)

260A

BMS 001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors