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Home > "A" Clinical Trials Conditions > A Third-Party Blinded, Placebo Controlled Comparative Study of AS-101 Administered Intravenously in HIV Positive Patients With Advanced Disease  A Third-Party Blinded, Placebo Controlled Comparative Study of AS-101 Administered Intravenously in HIV Positive Patients With Advanced Disease
A Third-Party Blinded, Placebo Controlled Comparative Study of AS-101 Administered Intravenously in HIV Positive Patients With Advanced Disease
For Condition: HIV Infections
Status: Completed
Sponsor(s): Wyeth-Ayerst Research ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Double-Blind
Minimum Age/Maximum Age: 13 Years/70 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Standard therapy including acyclovir or ganciclovir for infections that develop during the study period. (Prophylactic acyclovir is not permitted.) Standard therapy for persistent infections may continue. - Immunomodulators or specific therapy for malignancies (including Kaposi's sarcoma) allowed only with permission of Wyeth-Ayerst medical monitor. - Zidovudine (AZT) may be added only if there is disease progression and after the patient has been in the study for a minimum of eight weeks. - Garlic capsules will be given to all study participants to mask side effects of AS-101. - Required: - Accepted standard prophylaxis for patients with prior Pneumocystis carinii pneumonia (PCP). Patients must have the following: - Diagnosis of AIDS or AIDS-related complex (ARC). - Life expectancy > 6 months. - Provide written informed consent. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: - Evidence of severe liver dysfunction (serum albumin < 2.5 g/dl, prothrombin time > 15 seconds or SGOT or SGPT > 3 x upper limits of normal), gastrointestinal, renal, respiratory, endocrine, hematologic, cardiovascular system abnormalities or psychiatric disorders which would prevent compliance with the protocol. - Evidence of AIDS related dementia. - Presence of disseminated Kaposi's sarcoma defined as any visceral lesions or > 20 cutaneous lesions; or Kaposi's sarcoma without at least one other AIDS defining characteristic. - Presence of any lymphoma. - Active opportunistic infection currently requiring treatment unless the infection has stabilized and continuing treatment is only required to prevent relapse (e.g., CNS toxoplasmosis or resolving tuberculosis). Concurrent Medication: Excluded: - Prophylactic acyclovir. - Immunomodulators or specific therapy for malignancies (including Kaposi's sarcoma) allowed only with permission of Wyeth-Ayerst medical monitor. - Zidovudine (AZT) may be added only if there is disease progression and after the patient has been in the study for a minimum of eight weeks. Patients with the following are excluded: - Evidence of severe organ dysfunction as defined in Exclusion complications or other specified disease conditions. - Unlikely or unable to comply with the requirements of the protocol. Prior Medication: Excluded within 8 weeks of study entry: - Any immune stimulation agents such as BCG vaccine, interferons, or other immune modulators within 8 weeks. - Any immunosuppressive agent within 8 weeks. - Excluded within 12 weeks of study entry: - Zidovudine (AZT).
Total Enrollment:
Location and Contact Information:
Escola Paulista De-Medicina
Sao Paulo, ,
Brazil
Faculdade De-Ciencias Medica Da
Sao Paulo, ,
Brazil
Instituto Do Cancer Arnaldo Vieiro
Sao Paulo, ,
Brazil
Hosp De-Servidor Publico Estadual
Sao Paulo, ,
Brazil
Additional Information:
Study ID Numbers: 045A; 753A-202-BR,MX
Study Start Date:
Record last reviewed: February 1991
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002033
Other Hiv Infections Studies:
1. Prenatal and Postnatal Studies
2. A Study of AZT Plus Human Interferon Alpha in the Treatment of AIDS-Related Kaposi's Sarcoma
3. Prevalence of Hepatitis C Virus Infection in HIV-Infected Children
4. A Comparison of Two Types of Injected Nutritional Supplements in Patients with AIDS and Pneumocystis carinii Pneumonia (PCP)
5. A Study of Lobucavir in Patients with AIDS
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A Third-Party Blinded, Placebo Controlled Comparative Study of AS-101 Administered Intravenously in HIV Positive Patients With Advanced Disease
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