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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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NCT00002033

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Escola Paulista De-Medicina
Sao Paulo, , Brazil
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
HIV Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
13-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

- Evidence of severe liver dysfunction (serum albumin 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).

NCT00002033
Pfizer
Completed
A Third-Party Blinded, Placebo Controlled Comparative Study of AS-101 Administered Intravenously in HIV Positive Patients With Advanced Disease

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Pfizer Clinical Trials Contact Center

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[email protected]

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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.
Not Provided
Interventional
Not Provided
Masking: Double
Primary Purpose: Treatment
HIV Infections
  • Drug: Zidovudine
  • Drug: AS-101
Not Provided
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
Not Provided
Not Provided
Not Provided

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).
Sexes Eligible for Study: All
13 Years to 70 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT00002033
045A
753A-202-BR,MX
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Not Provided
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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