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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002033
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: February 1991

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002033 on ClinicalTrials.gov Archive Site
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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

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.

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Interventional
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Masking: Double-Blind
Primary Purpose: Treatment
HIV Infections
  • Drug: Zidovudine
  • Drug: AS-101
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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)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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).
Both
13 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00002033
045A, 753A-202-BR,MX
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Wyeth is now a wholly owned subsidiary of Pfizer
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NIH AIDS Clinical Trials Information Service
February 1991

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP