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| Sponsored by: |
Bristol-Myers Squibb |
| Information provided by: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00002307 |
Purpose
To compare stavudine (d4T) and zidovudine (AZT) in slowing the progression of HIV disease. To compare the antiviral activity of d4T versus AZT as measured by plasma levels of p24 antigen and HIV viremia, and their relative efficacy by improvement and/or absence of adverse changes over time in laboratory parameters associated with HIV infection. To compare the safety of oral doses of d4T to AZT in patients with HIV infection.
| Condition | Intervention |
|
HIV Infections |
Drug: Stavudine Drug: Zidovudine |
| MedlinePlus related topics: | AIDS |
| Drug Information available for: | Zidovudine Stavudine |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control, Single Group Assignment, Efficacy Study |
| Official Title: | A Double-Blind Comparison of Zidovudine (AZT) Versus Stavudine (d4T; BMY 27857) for the Treatment of Patients With HIV Infection Who Have Absolute CD4 Lymphocyte Counts Between 50 and 500 Cells/mm3 |
Eligibility
| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Required:
Contacts and Locations![]() |
Show 45 Study Locations |
| Bristol-Myers Squibb |
| Principal Investigator: | . ., . | . |
More Information
BMS Clinical Trials Disclosure 
  |
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm 
  |
| Study ID Numbers: | 116A, AI455-019 |
| First Received: | November 2, 1999 |
| Last Updated: | August 15, 2007 |
| ClinicalTrials.gov Identifier: | NCT00002307 |
| Health Authority: | United States: Food and Drug Administration |
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