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| Sponsor: | G D Searle |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002079 |
Purpose
To assess the dose-related antiviral effects of SC-48334 and zidovudine (AZT) administered in combination or individually in HIV-1 positive patients with 200 - 500 CD4+ cells/mm3. To determine the safety of escalating doses of SC-48334 when administered in combination with any of three doses of AZT to symptomatic HIV-1 positive patients with 200 - 500 CD4+ cells/mm3, and to assess the pharmacokinetics of the two drugs, given separately and in combination.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Butyldeoxynojirimycin Drug: Zidovudine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Dose Comparison, Pharmacokinetics Study |
| Official Title: | Phase II Study of the Safety and Surrogate Marker Efficacy of Butyldeoxynojirimycin (SC-48334) and AZT in Symptomatic HIV-1 Infected Patients With 200 - 500 CD4+ Cells/mm3. (NOTE: Asymptomatic HIV-1 Infected Patients Also Eligible) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
Whole-body irradiation within 6 months prior to study entry. Current use of illicit substances, or abuse of alcohol, which would limit compliance with the protocol.
Contacts and Locations| United States, California | |
| Dr Marcus Conant | |
| San Francisco, California, United States, 94115 | |
| Shared Med Research Foundation | |
| Tarzana, California, United States, 91356 | |
| United States, Florida | |
| Stratogen of South Florida | |
| Miami Beach, Florida, United States, 33140 | |
| Saint Joseph's Hosp / Infectious Disease Rsch Institute | |
| Tampa, Florida, United States, 33614 | |
| United States, Georgia | |
| West Paces Clinical Research Incoporated | |
| Atlanta, Georgia, United States, 30327 | |
| United States, Pennsylvania | |
| Dr Samuel W Golden | |
| Pittsburgh, Pennsylvania, United States, 15218 | |
| United States, Texas | |
| Dallas Veterans Administration Med Ctr | |
| Dallas, Texas, United States, 75216 | |
| Park Plaza Hosp | |
| Houston, Texas, United States, 77004 | |
| Dr Daniel Barbero | |
| Fort Worth, Texas, United States, 76104 | |
More Information
| Study ID Numbers: | 057B, NS8-91-02-009 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002079 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Zidovudine 1-Deoxynojirimycin |
|
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 |