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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

This study has been completed.
Study NCT00002419.   Last updated on June 23, 2005.   Information provided by NIH AIDS Clinical Trials Information Service

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Descriptive Information Fields
Brief Title  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
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
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.

Study Phase Phase II
Study Type  Interventional
Study Design  Treatment, Safety Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  HIV Infections
Intervention  Drug: Abacavir sulfate
Drug: Amprenavir
Drug: Efavirenz
Drug: Adefovir dipivoxil
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  25
Start Date 
Completion Date
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.
Gender Both
Ages 13 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00002419
Organization ID 299A
Secondary IDs †† ICC 605
Study Sponsor  Gilead Sciences
Collaborators †† Glaxo Wellcome
Dupont Pharmaceuticals
Investigators 
Information Provided By NIH AIDS Clinical Trials Information Service
Verification Date November 1999
First Received Date  November 2, 1999
Last Updated Date June 23, 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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