Completed

Cysteamine and Zidovudine for HIV Disease Treatment

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Study Aim

This phase 2 study aims to evaluate the effectiveness of Cysteamine and Zidovudine combination in treating HIV disease.

What is being tested

Cysteamine

+ Zidovudine

Drug
Who is being recruted

Blood-Borne Infections+13

+ Urogenital Diseases

+ Genital Diseases

Over 13 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
See protocol details

Summary

Principal SponsorMylan Laboratories
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

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.

NCT00002110
Principal SponsorMylan Laboratories
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

300 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 13 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAIDS-Related ComplexHIV Infections

Criteria

6 inclusion criteria required to participate
CD4 count 300 - 500 cells/mm3
Chemoprophylaxis for Pneumocystis carinii pneumonia, candidiasis, Mycobacterium tuberculosis, and herpes as prescribed by the investigator
Documented HIV infection
No past or current AIDS-defining opportunistic infection
Show More Criteria
12 exclusion criteria prevent from participating
Active malignancy other than basal cell carcinoma or in situ cervical carcinoma
Antiretroviral therapy other than AZT
Cytotoxic chemotherapy including Adriamycin, bleomycin, and vincristine
Hematopoietins
Show More Criteria

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 6 locations

Infectious Disease Research Institute Inc

Tampa, United StatesOpen Infectious Disease Research Institute Inc in Google Maps

Tulane Univ Med School

New Orleans, United States

SUNY / Health Sciences Ctr at Stony Brook

Stony Brook, United States

Bowman Gray School of Medicine / North Carolina Baptist Hosp

Winston-Salem, United States
Completed6 Study Centers