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| Sponsor: | Wyeth |
|---|---|
| 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: | Treatment, Double-Blind |
| 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
| Study ID Numbers: | 045A, 753A-202-BR,MX |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002033 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Acquired Immunodeficiency Syndrome AIDS-Related Complex ammonium trichloro(dioxoethylene-O,O'-)tellurute Zidovudine |
|
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 |