A Study of Amprenavir in HIV-Infected Patients

Not Applicable

Completed

• Conditions: HIV Infections

• Registration Number: NCT00002405
• Lead Sponsor: Glaxo Wellcome

Brief Summary

The purpose of this study is to see if it is safe to give amprenavir (APV) to HIV-infected patients. This study also examines the effect APV has on the level of HIV in the blood.

Earlier studies have shown that APV is effective in slowing the growth of HIV in the body. Patients who have failed previous anti-HIV treatment or who are unable to take other protease inhibitors (PIs) may benefit from the availability of a new PI such as APV.

Detailed Description

Earlier Phase II/III clinical trials indicate APV is effective in retarding HIV progression in the body. Despite these data, however, the drug has yet to receive regulatory approval. At the same time, there is an urgent need to grant pre-approval access to specific groups of patients eager to benefit from the anti-HIV potential inherent in APV. This study examines the relative effects APV has in patients with prior treatment failure or intolerance to previous protease inhibitor therapy.

Patients are seen in the clinic at pre-entry, baseline (Day 1), and every 4 weeks thereafter. Data on current antiretroviral treatment, HIV-1 associated conditions and adverse events are collected at every scheduled visit. Laboratory values (i.e., hematology, serum chemistry, plasma HIV-1 viral load and CD4+ cell count) are collected and assessed at pre-entry and Weeks 12, 24, 36, and 48. Optimal therapeutic effectiveness dictates the combined use of 2 or more antiretroviral agents in patients failing current antiretroviral therapy. APV, therefore, must be initiated as a component of a treatment regimen that also includes at least one other antiretroviral drug that the patient has not previously received.

Study Timeline

• Status Verified: 1999-04
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Glaxo Wellcome Inc; 🇺🇸 Research Triangle Park, North Carolina, United States