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| Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Bristol-Myers Squibb Glaxo Wellcome |
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000625 |
Purpose
To determine the efficacy and safety of zidovudine ( AZT ) versus didanosine ( ddI ), AZT plus ddI, and AZT plus zalcitabine ( ddC ) in preventing disease progression in HIV-infected patients with CD4 counts of 200-500 cells/mm3.
| Condition | Intervention | Phase |
|
HIV Infections |
Drug: Zidovudine Drug: Zalcitabine Drug: Didanosine |
Phase II |
| MedlinePlus related topics: | AIDS |
| Drug Information available for: | Zidovudine Didanosine Zalcitabine |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind, Safety Study |
| Official Title: | A Randomized, Double-Blind Phase II/III Trial of Monotherapy vs. Combination Therapy With Nucleoside Analogs in HIV-Infected Persons With CD4 Cells of 200-500/mm3 |
| Estimated Enrollment: | 2100 |
Patients are randomized to receive AZT alone, AZT and ddI, AZT and ddC, or ddI alone for at least 2 years. Patients who develop AIDS or whose CD4 count falls to 50 percent or less of baseline are crossed over to another treatment arm.
PER AMENDMENT 4/5/95: Study treatment will be available until 10/31/95 at the latest for patients still taking study medications on 4/30/95, so that follow-up trials may be completed and approved.
Eligibility
| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
PER AMENDMENT 4/5/95:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Current alcohol abuse.
Contacts and Locations![]() |
Show 128 Study Locations |
| National Institute of Allergy and Infectious Diseases (NIAID) |
| Bristol-Myers Squibb |
| Glaxo Wellcome |
| Study Chair: | Katzenstein D | |
| Study Chair: | Hammer S |
More Information
Click here for more information about Zidovudine 
  |
Click here for more information about Didanosine 
  |
| Study ID Numbers: | ACTG 175 |
| First Received: | November 2, 1999 |
| Last Updated: | August 6, 2008 |
| ClinicalTrials.gov Identifier: | NCT00000625 |
| Health Authority: | United States: Federal Government |
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