Safety and Effectiveness of Giving Adefovir Dipivoxil Plus Abacavir Plus Efavirenz Plus Amprenavir to HIV-Infected Patients Who Have Failed to Respond to Previous Protease Inhibitor Treatment

NCT ID: NCT00002419

Last Updated: 2005-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL

Brief Summary

The purpose of this study is to see if it is safe and effective to give adefovir dipivoxil plus abacavir (ABC) plus efavirenz (EFV) plus amprenavir (APV) to HIV-infected patients who have failed to respond to previous treatment with protease inhibitors (PIs).

Detailed Description

Patients receive a treatment regimen of adefovir dipivoxil, abacavir, efavirenz, and amprenavir for 24 weeks. During the study, patients are evaluated for changes from baseline in plasma HIV-1 RNA levels and lymphocyte subsets and for development of adverse events and toxicities. Patients who experience virologic failure are discontinued from the study. After Week 24, patients with documented virologic response are eligible to continue receiving the study treatment and to attend scheduled follow-up visits.

Conditions

HIV Infections

Study Design

• Primary Study Purpose: TREATMENT

Interventions

Abacavir sulfate

Intervention Type: DRUG

Amprenavir

Intervention Type: DRUG

Efavirenz

Intervention Type: DRUG

Adefovir dipivoxil

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

You may be eligible for this study if you:

• Are HIV-positive.
• Had an HIV level of at least 2,000 copies/ml after 6 months of treatment with at least 1 PI other than amprenavir (meaning you failed PI treatment).
• Are at least 13 years old (need consent of parent or guardian if under 18).
• Are able to complete the study.
• Agree to use effective barrier methods of birth control, such as condoms, during the study.

Exclusion Criteria

You will not be eligible for this study if you:

• Have certain serious medical conditions, including AIDS-related cancers (except Kaposi's sarcoma) that require treatment during the study.
• Have ever taken or are allergic to adefovir dipivoxil, ABC, APV, EFV.
• Are participating in another anti-HIV drug trial during this study.
• Have taken certain medications within 30 days prior to study entry, including medications that affect your immune system.
• Have been diagnosed with hepatitis within the past 30 days.
• Abuse alcohol or drugs.
• Are pregnant or breast-feeding.
• Have ever taken NNRTIs.
• Have ever taken ddI or d4T.
• Have received chemotherapy or radiation therapy within 30 days prior to study entry.

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Glaxo Wellcome

INDUSTRY

Sponsor Role: collaborator

Dupont Applied Biosciences

INDUSTRY

Sponsor Role: collaborator

Gilead Sciences

INDUSTRY

Sponsor Role: lead

Locations

Pacific Oaks Med Group

Beverly Hills, California, United States

Univ of Colorado / Health Science Ctr

Denver, Colorado, United States

AIDS Research Consortium of Atlanta

Atlanta, Georgia, United States

Brown Univ School of Medicine

Providence, Rhode Island, United States

Hampton Roads Med Specialists

Hampton, Virginia, United States

Countries

United States

Other Identifiers

ICC 605

Identifier Type: -

Identifier Source: secondary_id

299A

Identifier Type: -

Identifier Source: org_study_id