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The Safety and Effectiveness of 935U83 in HIV-Infected Patients Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on The Safety and Effectiveness of 935U83 in HIV-Infected Patients conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. The Safety and Effectiveness of 935U83 in HIV-Infected Patients Clinical research trials and The Safety and Effectiveness of 935U83 in HIV-Infected Patients medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like The Safety and Effectiveness of 935U83 in HIV-Infected Patients. The Safety and Effectiveness of 935U83 in HIV-Infected Patients Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a The Safety and Effectiveness of 935U83 in HIV-Infected Patients clinical trial. Participants frequently obtain the most expert healthcare available for their The Safety and Effectiveness of 935U83 in HIV-Infected Patients condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > The Safety and Effectiveness of 935U83 in HIV-Infected Patients  The Safety and Effectiveness of 935U83 in HIV-Infected Patients
The Safety and Effectiveness of 935U83 in HIV-Infected Patients
For Condition: HIV Infections
Status: Completed
Sponsor(s): Glaxo Wellcome ,
Synopsis: To assess the safety, tolerance, and steady-state pharmacokinetics of multiple oral doses of 935U83 administered to patients with HIV infection. To obtain preliminary evidence of antiretroviral activity of 935U83. To prospectively evaluate the emergence of in vitro drug resistance. To determine the effects of 935U83 dosing on CD4+ cell counts.
Details: Patients (10 per dose level) are randomized to receive 1 of 4 doses of 935U83 every 8 hours for 12 weeks. Five patients at each dose level must complete 4 weeks of treatment without serious toxicity before subsequent patients are entered at the next higher dose. If lack of antiretroviral effect or unacceptable toxicity is demonstrated at a particular dose level, the dose regimens may be adjusted.
Eligibility:
Study Type: Interventional, Treatment, Dose Comparison, Pharmacokinetics Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Recommended: - PCP prophylaxis for patients whose CD4 counts fall below 200 cells/mm3 or who develop PCP during study participation. Allowed: - Acute treatment and secondary prophylaxis for tuberculosis, Mycobacterium avium intracellulare, toxoplasmosis, histoplasmosis, cryptococcosis, disseminated candidiasis, or cytomegalovirus infection. Patients must have: - HIV infection. - CD4 count 200 - 500 cells/mm3. - No history of or current AIDS-defining indicator disease by CDC criteria. - No antiretroviral therapy within the past 6 months. - Consent of parent or guardian if less than 18 years of age. Exclusion Criteria Co-existing Condition: Patient with the following symptoms or conditions are excluded: - Current evidence of chronic hepatitis of any etiology. - Seropositivity for HBsAg or hepatitis C virus by second generation ELISA. Concurrent Medication: Excluded: - Cytotoxic chemotherapy. - Other antiretroviral drugs. - Immunomodulators. - Foscarnet. - GM-CSF or G-CSF. - Erythropoietin. Concurrent Treatment: Excluded: - Radiation therapy. Patients with the following prior conditions are excluded: History of chemical, viral, or alcohol-induced clinical hepatitis within the past 3 years. Prior Medication: Excluded within the past 6 months: - Any antiretroviral therapy. - HIV immunotherapeutic vaccine. Excluded within the past 4 weeks: - Cytotoxic chemotherapy. - Immunomodulating agents such as systemic corticosteroids, IL-2, alpha interferon, beta interferon, or gamma interferon. Prior Treatment: Excluded within the past 4 weeks: - Radiation therapy. Current alcohol or illicit drug use that may interfere with study compliance.
Total Enrollment: 40
Location and Contact Information:
Goodgame Med Group
Maitland, Florida, 32751
United States
Indiana Univ Hosp
Indianapolis, Indiana, 46202
United States
Univ of Pittsburgh Med School
Pittsburgh, Pennsylvania, 15261
United States
Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
ViRx Inc
San Francisco, California, 94103
United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
United States
Univ of Cincinnati / Holmes Hosp
Cincinnati, Ohio, 45267
United States
Additional Information:
Study ID Numbers: 237A; 02
Study Start Date:
Record last reviewed: April 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002338
Other Hiv Infections Studies:
1. A Study of d4T in Patients with AIDS or AIDS-Related Complex Who Cannot Take AZT
2. A Study on the Management of Combination Anti-HIV Drug Therapy in HIV-Positive Children with Prior Treatment
3. A Double-Blind, Randomized, Comparative Study of Delavirdine Mesylate (U-90152S) in Combination With Didanosine (ddI) Versus ddI Alone in HIV-1 Infected Individuals With CD4 Counts of <= 300/mm3
4. A Study of Dextran Sulfate in HIV-Infected Patients and in Patients with AIDS or AIDS Related Complex (ARC)
5. A Study of Patients with AIDS Syndrome
Related Studies:
Other HIV Infections Clinical Trials
Other Florida Clinical Trials
Other Maitland Clinical Trials
The Safety and Effectiveness of 935U83 in HIV-Infected Patients
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