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| Sponsor: | Wyeth is now a wholly owned subsidiary of Pfizer |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002033 |
Purpose
To compare the effect of AS-101 to that of placebo on clinical efficacy and immunologic function in HIV positive patients with advanced disease. To compare the effect of AS-101 to that of placebo on occurrence of disease progression in HIV positive patients with advanced disease as defined by: (1) development of new diagnostically confirmed major opportunistic infection(s); or (2) development of AIDS-related dementia. To compare the effect of zidovudine (AZT) plus AS-101 versus AZT alone (placebo arm) on clinical efficacy and immunologic function in patients who require anti-viral therapy due to disease progression. Garlic capsules will be given to all study participants to mask the obvious garlic odor of AS-101.
| Condition | Intervention |
|---|---|
|
HIV Infections |
Drug: Zidovudine Drug: AS-101 |
| Study Type: | Interventional |
| Study Design: | Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Third-Party Blinded, Placebo Controlled Comparative Study of AS-101 Administered Intravenously in HIV Positive Patients With Advanced Disease |
Eligibility| Ages Eligible for Study: | 13 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have the following:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Concurrent Medication:
Excluded:
Patients with the following are excluded:
Prior Medication:
Excluded within 8 weeks of study entry:
Contacts and Locations| Brazil | |
| Escola Paulista De-Medicina | |
| Sao Paulo, Brazil | |
| Instituto Do Cancer Arnaldo Vieiro | |
| Sao Paulo, Brazil | |
| Faculdade De-Ciencias Medica Da | |
| Sao Paulo, Brazil | |
| Hosp De-Servidor Publico Estadual | |
| Sao Paulo, Brazil | |
More Information
| ClinicalTrials.gov Identifier: | NCT00002033 History of Changes |
| Other Study ID Numbers: | 045A, 753A-202-BR,MX |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
|
Acquired Immunodeficiency Syndrome AIDS-Related Complex ammonium trichloro(dioxoethylene-O,O'-)tellurute Zidovudine |
|
HIV Infections Acquired Immunodeficiency Syndrome HIV Seropositivity 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 Ammonium trichloro(dioxoethylene-O,O'-)tellurate 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 Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents Radiation-Protective Agents |