A Third-Party Blinded, Placebo Controlled Comparative Study of AS-101 Administered Intravenously in HIV Positive Patients With Advanced Disease

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Zidovudine; Drug: AS-101

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil
    • Escola Paulista De-Medicina
  • Sao Paulo, Brazil
    • Faculdade De-Ciencias Medica Da
  • Sao Paulo, Brazil
    • Hosp De-Servidor Publico Estadual
  • Sao Paulo, Brazil
    • Instituto Do Cancer Arnaldo Vieiro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 70 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Masking: DOUBLE

Collaborators and Investigators

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Publications and helpful links

General Publications

• Amarante JM, Levi GC, Pedro RJ, Galvao PA, Scheinberg M, Levy DS. A double blind controlled study with AS-101 in patients infected with HIV. Int Conf AIDS. 1992 Jul 19-24;8(2):B160 (abstract no PoB 3439)

Study record dates

Study Registration Dates

• First Submitted: November 2, 1999
• First Submitted That Met QC Criteria: August 30, 2001
• First Posted (ESTIMATE): August 31, 2001

Study Record Updates

• Last Update Posted (ESTIMATE): June 24, 2005
• Last Update Submitted That Met QC Criteria: June 23, 2005
• Last Verified: February 1, 1991

More Information

Terms related to this study

• Keywords: Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Zidovudine; ammonium trichloro(dioxoethylene-O,O'-)tellurute
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; HIV Seropositivity; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Antimetabolites; Zidovudine
• Other Study ID Numbers: 045A; 753A-202-BR,MX