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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 March 15, 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.
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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.
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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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[email protected]

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