Completed

Evaluation of Safety, Pharmacokinetics and Antiviral Activity of 141W94 in HIV-Infected Patients

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Abacavir sulfate

+ Amprenavir

+ Lamivudine

Drug
Who is being recruted

Blood-Borne Infections+11

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
See protocol details

Summary

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

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.

Principal SponsorGlaxo Wellcome
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

60 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 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

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

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

UCSD

San Diego, United StatesOpen UCSD in Google Maps

Univ of Colorado Health Sciences Ctr

Denver, United States

AIDS Research Consortium of Atlanta

Atlanta, United States
Completed3 Study Centers