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A Phase I Trial to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of 141W94 After Multiple Dosing in Patients with HIV Infection Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on A Phase I Trial to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of 141W94 After Multiple Dosing in Patients with HIV Infection conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Phase I Trial to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of 141W94 After Multiple Dosing in Patients with HIV Infection Clinical research trials and A Phase I Trial to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of 141W94 After Multiple Dosing in Patients with HIV Infection healthcare trials happen in a lot of of localities across 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 generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as A Phase I Trial to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of 141W94 After Multiple Dosing in Patients with HIV Infection. A Phase I Trial to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of 141W94 After Multiple Dosing in Patients with HIV Infection Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a A Phase I Trial to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of 141W94 After Multiple Dosing in Patients with HIV Infection clinical trial. Human subjects often receive the most effective healthcare possible for their A Phase I Trial to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of 141W94 After Multiple Dosing in Patients with HIV Infection condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Phase I Trial to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of 141W94 After Multiple Dosing in Patients with HIV Infection  A Phase I Trial to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of 141W94 After Multiple Dosing in Patients with HIV Infection
A Phase I Trial to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of 141W94 After Multiple Dosing in Patients with HIV Infection
For Condition: HIV Infections
Status: Completed
Sponsor(s): Glaxo Wellcome ,
Synopsis: To assess the safety and tolerance of multiple oral doses of 141W94 alone, in combination with 1592U89, and in combination with Retrovir and Epivir, administered to patients with HIV infection as measured by the development of clinical adverse experiences and laboratory test abnormalities. To determine the steady-state pharmacokinetics of 141W94 alone and in combination with 1592U89 after multiple oral dosing. To obtain preliminary evidence of antiretroviral activity of 141W94 alone and in combination with 1592U89, the antiretroviral effect of combined Retrovir/Epivir and the antiretroviral effect of 141W94 when added to Retrovir/Epivir or to 1592U89/Retrovir/Epivir.
Details: 60 HIV-infected patients will be sequentially assigned to receive 1 of 5 doses of 141W94 alone or 141W94 plus 1592U89. After each patient has completed 4 weeks of the assigned regimen (Phase A), the patient will receive Epivir and Retrovir for up to 8 months (Phase B). Patients originally assigned, in Phase A, to receive 141W94 and 1592U89 continue to receive 1592U89 during this period. Upon termination of Phase B, 141W94 is added to existing regimens of Phase B (Phase C). Phase C will last for 12 weeks.
Eligibility:
Study Type: Interventional, Treatment, Dose Comparison, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Localized therapy such as intralesional injections for Kaposi's sarcoma. Patients must have: - HIV infection documented by a licensed HIV antibody ELISA confirmed by: - Western blot, or positive HIV blood culture, or positive HIV serum antigen and second antibody test positive by a method other than ELISA. - CD4+ counts >= 150 and <= 400 cells/mm3 within 2 weeks of study entry. 1. Anticipated need for cytotoxic chemotherapeutic agents within 4 weeks prior to entry. - Alprazolam, carbamazepine, codeine, clarithromycin, dapsone, diazepam, diltiazem, erythromycin, estrogens, glucocorticoids, imipramine, itraconazole, ketoconazole, lidocaine, lovastatin, nifedipine, phenobarbital, phenytoin, quinidine, rifabutin, rifampin and warfarin. - The following medications should be used with caution in most instances or not at all: - terfenadine, astemizole, cisapride, triazolam and midazolam. Anticipated need for treatment with radiation therapy within 4 weeks prior to entry. 1. Treatment with cytotoxic chemotherapeutic agents within 4 weeks prior to entry. - Patients who have previously received a protease inhibitor. - Antiretroviral therapy within 2 weeks prior to enrollment. NOTE: - Patients with a known intolerance to either retrovir or epivir are not eligible for Phase B of this study. NOTE: - Patients with previous epivir (3TC) experience will not be eligible for Regimen 6 of this study (combination therapy with 141W94 and 1592U89). - Treatment with immunomodulating agents, including but not limited to systemic corticosteroids, IL-2, alpha-IFN, beta-IFN, or gamma-IFN within 4 weeks prior to entry. - Treatment with HIV immunotherapeutic vaccine within 3 months prior to entry. Treatment with radiation therapy within 4 weeks prior to entry. Patients with current alcohol or illicit drug use which, in the opinion of the principal investigator, may interfere with the patients' ability to comply with the dosing schedule and protocol evaluations.
Total Enrollment: 60
Location and Contact Information:
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
United States
UCSD
San Diego, California, 92103
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Additional Information:
Study ID Numbers: 264B;
Study Start Date:
Record last reviewed: July 1997
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002183
Other Hiv Infections Studies:
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2. A Study to Evaluate the Effect of Cimetidine on CD4 Lymphocyte Counts in HIV Infection
3. T-20 with Anti-HIV Combination Therapy for Patients with Prior Anti-HIV Drug Treatment and/or Drug Resistance to Each of the Three Classes of Approved Anti-HIV Drugs
4. A Comparison of Two Types of Injected Nutritional Supplements in Patients with AIDS and Pneumocystis carinii Pneumonia (PCP)
5. Setting up a Blood Bank for Gene Therapy in HIV-Infected Infants
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A Phase I Trial to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of 141W94 After Multiple Dosing in Patients with HIV Infection
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