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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Collaborators: |
G D Searle Glaxo Wellcome |
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000791 |
Purpose
To determine the safety and anti-HIV activity of two doses of SC-49483 in combination with zidovudine (AZT) versus AZT alone. To determine the influences of viral phenotype on the anti-HIV activity of these treatment regimens.
SC-49483 has no inherent activity against HIV-1 but is converted in the intestinal wall to SC-48334, which has demonstrated anti-HIV activity. Since SC-49483 causes significantly less gastrointestinal toxicity than SC-48334, the combination of SC-49483 with AZT may improve the benefits of both drugs in patients with HIV infection.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Glycovir Drug: Zidovudine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind, Safety Study |
| Official Title: | A Phase II Double-Blind Study of Two Doses of SC-49483 in Combination With Zidovudine (ZDV) Versus ZDV |
| Estimated Enrollment: | 210 |
SC-49483 has no inherent activity against HIV-1 but is converted in the intestinal wall to SC-48334, which has demonstrated anti-HIV activity. Since SC-49483 causes significantly less gastrointestinal toxicity than SC-48334, the combination of SC-49483 with AZT may improve the benefits of both drugs in patients with HIV infection.
Patients are randomized to receive AZT alone or in combination with one of two doses of SC-49483, administered three times daily. Treatment continues for 16 to 24 weeks. Per 07/19/94 amendment: At the end of 24 weeks, blinded treatment continues for an additional 4 weeks, at which time patients may receive open-label drug on an optional basis for 90 days.
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Required:
Allowed:
Concurrent Treatment:
Allowed:
Patients must have:
NOTE:
Exclusion Criteria
Co-existing Condition:
Patients with the following condition are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Contacts and Locations
Show 42 Study Locations| Study Chair: | Fischl MA | |
| Study Chair: | Saag M |
More Information
| Study ID Numbers: | ACTG 259 |
| Study First Received: | November 2, 1999 |
| Last Updated: | August 25, 2008 |
| ClinicalTrials.gov Identifier: | NCT00000791 History of Changes |
| Health Authority: | United States: Federal Government |
|
Drug Therapy, Combination Acquired Immunodeficiency Syndrome AIDS-Related Complex Antiviral Agents Zidovudine |
|
Antimetabolites Anti-Infective Agents RNA Virus Infections Sexually Transmitted Diseases, Viral Anti-HIV Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Acquired Immunodeficiency Syndrome Zidovudine Enzyme Inhibitors Infection |
Antiviral Agents Pharmacologic Actions Immunologic Deficiency Syndromes Reverse Transcriptase Inhibitors Virus Diseases Anti-Retroviral Agents HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections Nucleic Acid Synthesis Inhibitors |