HIV Infections Clinical Trial
Official title:
An Open Label, Randomized, Comparative Study of Zerit (d4T) + Videx (ddI) + Crixivan Versus Retrovir (AZT) + Epivir (3TC) + Crixivan in HIV-Infected, Antiretroviral Naive Subjects With CD4 Cell Counts of 200 - 700/mm3 and HIV RNA Baseline Copy Number of >= 10,000 Copies/ml
| NCT number | NCT00002168 |
| Other study ID # | 260B |
| Secondary ID | BMS 002 |
| Status | Completed |
| Phase | N/A |
| First received | November 2, 1999 |
| Last updated | October 1, 2007 |
| Verified date | October 2007 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The purpose of this study is to compare the safety and effectiveness of two anti-HIV drug combinations when given to HIV-infected patients who have never been treated with anti-HIV drugs. One drug combination is stavudine (d4T) plus didanosine (ddI) plus Crixivan. The other combination is Retrovir (AZT) plus Epivir (3TC) plus Crixivan.
| Status | Completed |
| Enrollment | 200 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 16 Years and older |
| Eligibility |
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. |
Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Puerto Rico | Hosp Regional de Ponce - Area Vieja | Ponce | |
| United States | East Bay AIDS Clinic | Berkeley | California |
| United States | Univ of North Carolina / Infectious Disease Division | Chapel Hill | North Carolina |
| United States | The Nalle Clinic / Clinical Research Dept | Charlotte | North Carolina |
| United States | Chicago Ctr for Clinical Research | Chicago | Illinois |
| United States | Northwestern Univ | Chicago | Illinois |
| United States | Southwest Infectious Disease Association / PA | Dallas | Texas |
| United States | Univ of Texas Southwestern Med Ctr of Dallas | Dallas | Texas |
| United States | Univ of Nebraska | Omaha | Nebraska |
| United States | Univ of Pennsylvania / Infectious Diseases Division | Philadelphia | Pennsylvania |
| United States | Harbor UCLA Med Ctr / Division of Immunology / N-24 | Torrance | California |
| United States | Anderson Clinical Research | Washington | District of Columbia |
| United States | George Washington Med Ctr / Clinical Trials Unit | Washington | District of Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
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