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| Sponsors and Collaborators: |
Hoffmann-La Roche National Institute of Allergy and Infectious Diseases (NIAID) Glaxo Wellcome |
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000754 |
Purpose
To determine the safety and efficacy of two doses of interferon alfa-2a ( IFN alfa-2a ) in combination with zidovudine ( AZT )/zalcitabine ( ddC ) versus AZT/ddC only in patients with HIV infection and CD4 count < 400 cells/mm3.
AZT and ddC inhibit HIV by acting as reverse transcriptase chain terminators, while IFN alfa-2a inhibits translation of viral proteins. Combining agents that act at different sites of viral replication may improve HIV inhibition and produce more effective and sustained anti-HIV effects.
| Condition | Intervention | Phase |
|
HIV Infections |
Drug: Interferon alfa-2a Drug: Zidovudine Drug: Zalcitabine |
Phase II |
| MedlinePlus related topics: | AIDS |
| ChemIDplus related topics: | Zidovudine Interferon alfa-n1 Interferon alfa-2a Interferon alfa-2b Interferons Zalcitabine |
| Study Type: | Interventional |
| Study Design: | Treatment, Safety Study |
| Official Title: | A Randomized Phase II Study of Two Doses of Interferon Alfa-2a (IFN Alfa-2a) in Combination With Zidovudine (AZT) and Dideoxycytidine (ddC) Versus AZT and ddC Only in Patients With HIV Infection and Less Than 400 CD4 Cells/mm3 |
| Estimated Enrollment: | 60 |
AZT and ddC inhibit HIV by acting as reverse transcriptase chain terminators, while IFN alfa-2a inhibits translation of viral proteins. Combining agents that act at different sites of viral replication may improve HIV inhibition and produce more effective and sustained anti-HIV effects.
Patients are randomly assigned to one of three treatment arms to receive AZT/ddC alone or combined with one of two doses of IFN alfa-2a. Treatment continues for up to 12 months after enrollment of the last patient. Patients are followed at 2, 4, and 8 weeks and every 8 weeks thereafter. Mean duration of follow-up is expected to be 13 months.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
NOTE:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Active substance abuse.
Contacts and Locations| United States, Alabama | |||||
| Univ of Alabama at Birmingham | |||||
| Birmingham, Alabama, United States, 35294 | |||||
| United States, California | |||||
| Univ of California / San Diego Treatment Ctr | |||||
| San Diego, California, United States, 921036325 | |||||
| UCSD Med Ctr / Pediatrics / Clinical Sciences | |||||
| La Jolla, California, United States, 920930672 | |||||
| United States, Florida | |||||
| Univ of Miami School of Medicine | |||||
| Miami, Florida, United States, 331361013 | |||||
| Hoffmann-La Roche |
| National Institute of Allergy and Infectious Diseases (NIAID) |
| Glaxo Wellcome |
| Study Chair: | Fischl MA | |
| Study Chair: | Richman DD |
More Information
Click here for more information about Zidovudine 
  |
Click here for more information about Zalcitabine 
  |
Click here for more information about Interferon alfa-2a 
  |
| Study ID Numbers: | ACTG 197 |
| First Received: | November 2, 1999 |
| Last Updated: | July 29, 2008 |
| ClinicalTrials.gov Identifier: | NCT00000754 |
| Health Authority: | Unspecified |
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