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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: | Endpoint Classification: Pharmacokinetics Study Primary Purpose: Treatment |
| 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 | |
| Dr Daniel Barbero | |
| Fort Worth, Texas, United States, 76104 | |
| Park Plaza Hosp | |
| Houston, Texas, United States, 77004 | |
More Information
| ClinicalTrials.gov Identifier: | NCT00002079 History of Changes |
| Other Study ID Numbers: | 057B, NS8-91-02-009 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
|
Zidovudine 1-Deoxynojirimycin |
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Zidovudine |
Miglustat Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |