Evaluation of Safety, Pharmacokinetics and Antiviral Activity of 141W94 in HIV-Infected Patients
Abacavir sulfate
+ Amprenavir
+ Lamivudine
Blood-Borne Infections+11
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.60 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 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
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.
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 3 locations
Univ of Colorado Health Sciences Ctr
Denver, United StatesAIDS Research Consortium of Atlanta
Atlanta, United States