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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002419
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Glaxo Wellcome
Dupont Applied Biosciences
Information provided by:
NIH AIDS Clinical Trials Information Service

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).

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Abacavir sulfate Drug: Amprenavir Drug: Efavirenz Drug: Adefovir dipivoxil Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 25 participants
Primary Purpose: Treatment
Official Title: A Phase II, 24-Week, Open-Label Study Designed to Evaluate the Safety, Tolerability, and Efficacy of Novel Quadruple-Combination Therapy With Preveon (Adefovir Dipivoxil; Bis-POM PMEA), Abacavir (1592U89), Sustiva (Efavirenz; DMP-266), and Amprenavir (141W94) for the Treatment of HIV-1 Infection in Patients Who Have Failed Previous Protease Inhibitor Treatment

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002419

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United States, California
Pacific Oaks Med Group
Beverly Hills, California, United States, 90211
United States, Colorado
Univ of Colorado / Health Science Ctr
Denver, Colorado, United States, 80262
United States, Georgia
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308
United States, Rhode Island
Brown Univ School of Medicine
Providence, Rhode Island, United States, 02908
United States, Virginia
Hampton Roads Med Specialists
Hampton, Virginia, United States, 23666
Sponsors and Collaborators
Gilead Sciences
Glaxo Wellcome
Dupont Applied Biosciences
Layout table for additonal information Identifier: NCT00002419    
Other Study ID Numbers: 299A
ICC 605
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: November 1999
Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination
HIV Protease Inhibitors
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Additional relevant MeSH terms:
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Adefovir dipivoxil
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers
Anti-HIV Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
HIV Protease Inhibitors
Protease Inhibitors