A Third-Party Blinded, Placebo Controlled Comparative Study of AS-101 Administered Intravenously in HIV Positive Patients With Advanced Disease
NCT00002033
ABOUT THIS STUDY
FOR MORE INFORMATION
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Adult Trials: 18+ Years
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.
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).
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| Descriptive Information | |||
|---|---|---|---|
| Brief Title ICMJE | A Third-Party Blinded, Placebo Controlled Comparative Study of AS-101 Administered Intravenously in HIV Positive Patients With Advanced Disease | ||
| Official Title ICMJE | A Third-Party Blinded, Placebo Controlled Comparative Study of AS-101 Administered Intravenously in HIV Positive Patients With Advanced Disease | ||
| Brief Summary | 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. | ||
| Detailed Description | Not Provided | ||
| Study Type ICMJE | Interventional | ||
| Study Phase ICMJE | Not Applicable | ||
| Study Design ICMJE | Masking: Double Primary Purpose: Treatment | ||
| Condition ICMJE | HIV Infections | ||
| Intervention ICMJE |
| ||
| Study Arms ICMJE | Not Provided | ||
| 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) | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||
| Recruitment Information | |||
| Recruitment Status ICMJE | Completed | ||
| Enrollment ICMJE | Not Provided | ||
| Original Enrollment ICMJE | Not Provided | ||
| Study Completion Date ICMJE | Not Provided | ||
| Primary Completion Date | Not Provided | ||
| Eligibility Criteria ICMJE | 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:
| ||
| Sex/Gender ICMJE |
| ||
| Ages ICMJE | 13 Years to 70 Years (Child, Adult, Older Adult) | ||
| Accepts Healthy Volunteers ICMJE | No | ||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
| Listed Location Countries ICMJE | Brazil | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number ICMJE | NCT00002033 | ||
| Other Study ID Numbers ICMJE | 045A 753A-202-BR,MX | ||
| Has Data Monitoring Committee | Not Provided | ||
| U.S. FDA-regulated Product | Not Provided | ||
| IPD Sharing Statement ICMJE | Not Provided | ||
| Responsible Party | Not Provided | ||
| Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | ||
| Collaborators ICMJE | Not Provided | ||
| Investigators ICMJE | Not Provided | ||
| PRS Account | NIH AIDS Clinical Trials Information Service | ||
| Verification Date | February 1991 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||