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

Last updated on October 12, 2019

FOR MORE INFORMATION
Study Location
Escola Paulista De-Medicina
Sao Paulo, , Brazil
Contact
1-800-718-1021
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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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 SummaryTo 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 DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Masking: Double
Primary Purpose: Treatment
Condition  ICMJE HIV Infections
Intervention  ICMJE
  • Drug: Zidovudine
  • Drug: AS-101
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 DateNot Provided
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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 CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS AccountNIH AIDS Clinical Trials Information Service
Verification DateFebruary 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 the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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