Clinical trial NCT00002033: A Third-Party Blinded, Placebo Controlled Comparative Study of AS-101 Administered Intravenously in HIV Positive Patients With Advanced Disease
Official title: A Third-Party Blinded, Placebo Controlled Comparative Study of AS-101 Administered Intravenously in HIV Positive Patients With Advanced Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Acquired Immunodeficiency Syndrome
AIDS-Related Complex
ammonium trichloro(dioxoethylene-O,O'-)tellurute
Zidovudine
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 13
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.


Eligibility 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).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Escola Paulista De-Medicina
city: Sao Paulo
country: Brazil
facility: Faculdade De-Ciencias Medica Da
city: Sao Paulo
country: Brazil
facility: Hosp De-Servidor Publico Estadual
city: Sao Paulo
country: Brazil
facility: Instituto Do Cancer Arnaldo Vieiro
Study officials:
References:
citation: 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)