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


N/A
13 Years
70 Years
Not Enrolling
Both
HIV Infections

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Trial Information

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

Inclusion Criteria


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).

Type of Study:

Interventional

Study Design:

Masking: Double-Blind, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

045A

NCT ID:

NCT00002033

Start Date:

Completion Date:

Related Keywords:

  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • AIDS-Related Complex
  • ammonium trichloro(dioxoethylene-O,O'-)tellurute
  • Zidovudine
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • HIV Seropositivity

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