Clinical trial NCT00002013: A Safety, Pilot Pharmacokinetics and Neurocognitive Study of AS-101 in Combination With Zidovudine in AIDS/ARC Patients
Official title: A Safety, Pilot Pharmacokinetics and Neurocognitive Study of AS-101 in Combination With Zidovudine in AIDS/ARC Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Drug Therapy, Combination
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): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To evaluate safety, pharmacokinetics, immunologic parameters and neurocognitive data for three dosages of AS-101 in combination with zidovudine (AZT) in patients with AIDS or AIDS related complex (ARC).


Eligibility criteria: Inclusion Criteria

Concurrent Medication:

Required:

* Zidovudine (AZT).
* Aerosolized pentamidine for Pneumocystis carinii pneumonia (PCP) prophylaxis.
* Allowed ONLY with permission of the Wyeth-Ayerst medical monitor:
* Standard therapy for infections that develop during the study period.
* Oral acyclovir.
* Nystatin.
* Ketoconazole.
* Immunomodulators.
* Specific therapy for malignancies (including Kaposi's sarcoma).

Patients must have the following:

* Diagnosis of AIDS or AIDS related complex (ARC).
* Provide informed written consent.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Active opportunistic infection or malignancy requiring treatment at study entry.
* Prior history of psychiatric illness or head injury which in the judgment of the neuropsychologist would impair interpretation of the neurocognitive data.
* Evidence of central nervous system (CNS) opportunistic infection or malignancy.
* Serious underlying medical problems, including insulin- dependent diabetes mellitus, unstable ASHD (atherosclerotic heart disease) or uncontrolled hypertension, which may complicate interpretation of treatment results.
* Dementia.
* Evidence of = or \> 2 + proteinuria at study entry.

Concurrent Medication:

Excluded without permission of the Wyeth-Ayerst medical monitor:

* Immunomodulators.
* Specific therapy for malignancies (including Kaposi's sarcoma).

Patients with the following are excluded:

* Active opportunistic infection or malignancy requiring treatment at study entry.
* Prior history of psychiatric illness or head injury which in the judgment of the neuropsychologist would impair interpretation of the neurocognitive data.
* Evidence of conditions listed in the Patient Exclusion Co-existing Conditions.
* Active substance abuse.
* Unlikely or unable to comply with the requirements of the protocol.

Prior Medication:

Excluded within 8 weeks of study entry:

* Immunomodulators.
* Antiviral therapy, except zidovudine.
* Excluded within 2 weeks of study entry:
* Intravenous or oral acyclovir.
* Excluded within 3 months of study entry:
* Ribavirin.

Required:

* Zidovudine at a dose of = or \> 1000 mg/day for at least 6 weeks prior to study entry.

Active substance abuse.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Los Angeles County - USC Med Ctr
state: California
Study officials:
References:
citation: Laporate JP, Frottier J, Dormont D, Imbert JC, Albeck M, Najman A. As 101 in association with azt in AIDS patients: a phase I pilot study. Int Conf AIDS. 1989 Jun 4-9;5:405 (abstract no WBP320)