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| Sponsor: | Wyeth |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002013 |
Purpose
To evaluate safety, pharmacokinetics, immunologic parameters and neurocognitive data for three dosages of AS-101 in combination with zidovudine (AZT) in patients with AIDS or AIDS related complex (ARC).
| Condition | Intervention |
|---|---|
|
HIV Infections |
Drug: Zidovudine Drug: AS-101 |
| Study Type: | Interventional |
| Study Design: | Treatment, Dose Comparison, Pharmacokinetics Study |
| Official Title: | A Safety, Pilot Pharmacokinetics and Neurocognitive Study of AS-101 in Combination With Zidovudine in AIDS/ARC Patients |
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Required:
Patients must have the following:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Concurrent Medication:
Excluded without permission of the Wyeth-Ayerst medical monitor:
Patients with the following are excluded:
Prior Medication:
Excluded within 8 weeks of study entry:
Required:
Active substance abuse.
Contacts and Locations
More Information
| Study ID Numbers: | 045C, 753A-109-US |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002013 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Drug Therapy, Combination Acquired Immunodeficiency Syndrome AIDS-Related Complex ammonium trichloro(dioxoethylene-O,O'-)tellurute Zidovudine |
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Antimetabolites Anti-Infective Agents Radiation-Protective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Zidovudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections |
Nucleic Acid Synthesis Inhibitors RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Adjuvants, Immunologic Enzyme Inhibitors Protective Agents Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases HIV Infections Ammonium trichloro(dioxoethylene-O,O'-)tellurate Sexually Transmitted Diseases |