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
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
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).
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Honolulu, Hawaii
- Philadelphia, Pennsylvania
- New York, New York
- Amsterdam,
- Amsterdam,
- Amsterdam,
- Arnhem,
- Haarlem,
- Leiden,
- Rotterdam,
- Rotterdam,
- Tilburg,
- Utrecht,
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 |