Clinical trial NCT00002110: A Phase II/III Study of Cysteamine (Mercaptoethylamine) and Zidovudine for the Treatment of HIV Disease
Official title: A Phase II/III Study of Cysteamine (Mercaptoethylamine) and Zidovudine for the Treatment of HIV Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: Drug Therapy, Combination
AIDS-Related Complex
Zidovudine
Cysteamine
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 300
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To determine the safety and tolerance of low-dose versus high-dose cysteamine administered concurrently with zidovudine (AZT). To determine the pharmacokinetics and effects on immune function and viral load in patients receiving these drug regimens.

Detailed description: Patients receive high or low doses of cysteamine plus AZT or placebo plus AZT. The target dose of cysteamine is determined by titration of the dose over a 6-week period, after which the patient receives 24 additional weeks of treatment. An initial cohort of 36 patients will be enrolled in a 10-week pilot phase. Accrual will be temporarily suspended while data from the pilot phase is assessed.

Eligibility criteria: Inclusion Criteria

Concurrent Medication:

Allowed:

* Chemoprophylaxis for Pneumocystis carinii pneumonia, candidiasis, Mycobacterium tuberculosis, and herpes as prescribed by the investigator.
* Recombinant erythropoietin and G-CSF if clinically indicated.

Patients must have:

* Documented HIV infection.
* CD4 count 300 - 500 cells/mm3.
* Prior AZT therapy for at least 3 months but less than 12 months prior to study entry.
* No past or current AIDS-defining opportunistic infection.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Kaposi's sarcoma requiring systemic therapy.
* Active malignancy other than basal cell carcinoma or in situ cervical carcinoma.

Concurrent Medication:

Excluded:

* Antiretroviral therapy other than AZT.
* Immunosuppressive drugs.
* Investigational HIV drugs/therapies other than study drug.
* Interferon.
* Steroids.
* Hematopoietins.
* Cytotoxic chemotherapy including Adriamycin, bleomycin, and vincristine.

Concurrent Treatment:

Excluded:

* Radiation therapy.

Patients with the following prior condition are excluded:

History of treatment-limiting intolerance to 500-600 mg AZT daily as manifested by the same recurrent grade 3 toxicity or any prior grade 4 toxicity.

Prior Medication:

Excluded:

* Prior antiretroviral therapy other than AZT.

Required:

* AZT for at least 3 months but no more than 12 months prior to study entry.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Infectious Disease Research Institute Inc
state: Florida
city: New Orleans
country: United States
facility: Tulane Univ Med School
state: Louisiana
city: Stony Brook
country: United States
facility: SUNY / Health Sciences Ctr at Stony Brook
state: New York
city: Winston Salem
country: United States
facility: Bowman Gray School of Medicine / North Carolina Baptist Hosp
state: North Carolina
city: Cranston
country: United States
facility: Independent Research Nurses Inc
state: Rhode Island
city: Dallas
country: United States
facility: Univ of Texas Southwestern Med Ctr of Dallas
state: Texas
Study officials:
References: