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A Phase II/III Study of Cysteamine (Mercaptoethylamine) and Zidovudine for the Treatment of HIV Disease Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about A Phase II/III Study of Cysteamine (Mercaptoethylamine) and Zidovudine for the Treatment of HIV Disease conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Phase II/III Study of Cysteamine (Mercaptoethylamine) and Zidovudine for the Treatment of HIV Disease Clinical research trials and A Phase II/III Study of Cysteamine (Mercaptoethylamine) and Zidovudine for the Treatment of HIV Disease healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as A Phase II/III Study of Cysteamine (Mercaptoethylamine) and Zidovudine for the Treatment of HIV Disease. A Phase II/III Study of Cysteamine (Mercaptoethylamine) and Zidovudine for the Treatment of HIV Disease Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a A Phase II/III Study of Cysteamine (Mercaptoethylamine) and Zidovudine for the Treatment of HIV Disease clinical trial. Subjects frequently obtain the most expert healthcare possible for their A Phase II/III Study of Cysteamine (Mercaptoethylamine) and Zidovudine for the Treatment of HIV Disease condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Phase II/III Study of Cysteamine (Mercaptoethylamine) and Zidovudine for the Treatment of HIV Disease  A Phase II/III Study of Cysteamine (Mercaptoethylamine) and Zidovudine for the Treatment of HIV Disease
A Phase II/III Study of Cysteamine (Mercaptoethylamine) and Zidovudine for the Treatment of HIV Disease
For Condition: HIV Infections
Status: Completed
Sponsor(s): Mylan Laboratories ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Double-Blind, Pharmacokinetics Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 300
Location and Contact Information:
SUNY / Health Sciences Ctr at Stony Brook
Stony Brook, New York, 117948153
United States
Bowman Gray School of Medicine / North Carolina Baptist Hosp
Winston Salem, North Carolina, 271571042
United States
Independent Research Nurses Inc
Cranston, Rhode Island, 02910
United States
Infectious Disease Research Institute Inc
Tampa, Florida, 33614
United States
Tulane Univ Med School
New Orleans, Louisiana, 701122699
United States
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235
United States
Additional Information:
Study ID Numbers: 211A; CYST-9304
Study Start Date:
Record last reviewed: October 1995
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002110
Other Hiv Infections Studies:
1. A Phase I/II Pilot Treatment Study Of CSF Penetration And Response To Ganciclovir And Foscarnet In CMV Neurologic Disease.
2. A Study to Evaluate the Effects of Giving IL-2 Alone to HIV-Positive Patients with CD4 Cell Counts of at Least 350 Cells/mm3 Who Do Not Wish to Receive Anti-HIV Therapy
3. Strategies for Delivering Anti-HIV Therapy in South Africa
4. Phase II Study of Novantrone(R) (Mitoxantrone) and Etoposide in Patients with HIV Associated Large Cell and Immunoblastic Lymphomas
5. A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV (vCP205) in HIV-1 Uninfected Adult Volunteers
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A Phase II/III Study of Cysteamine (Mercaptoethylamine) and Zidovudine for the Treatment of HIV Disease
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