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Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients

This study has been completed.
Study NCT00002234.   Last updated on .   Information provided by Bristol-Myers Squibb

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Descriptive Information Fields
Brief Title  Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients
Official Title  A Phase II, 48 Week, Open-Label Study Designed to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of a Simplified Dosing Regimen of Preveon (Adefovir Dipivoxil; bis-POM PMEA), Videx (Didanosine; ddI), Sustiva (Efavirenz; DMP-266), and Epivir (Lamivudine; 3TC) Administered Once Daily for the Treatment of HIV-1 Infection
Brief Summary

The purpose of this study is to see if it is safe and effective to give HIV-infected patients a new combination of anti-HIV drugs taken once daily.

Detailed Description

Patients receive a treatment regimen of adefovir dipivoxil, didanosine, efavirenz, and lamivudine for 48 weeks. During the study, patients are evaluated for changes from baseline in plasma HIV-1 RNA and lymphocyte subsets and for the development of adverse experiences and laboratory toxicities. At Weeks 8, 12, 24, and 48, patients are assessed for adherence to study treatment with a questionnaire. Patients who experience virologic failure are discontinued from the study. Patients who experience treatment intolerance may have their antiretroviral treatment regimens changed. After Week 48, patients with documented virologic response are eligible to continue receiving study treatment.

Study Phase Phase II
Study Type  Interventional
Study Design  Treatment, Safety Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  HIV Infections
Intervention  Drug: Efavirenz
Drug: Adefovir dipivoxil
Drug: Lamivudine
Drug: Didanosine
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.
  • Are at least 13 years old (need consent of parent or guardian if under 18).
  • Have an HIV count of 5,000 copies/ml or more within 30 days prior to study entry.
  • Have a CD4+ count of 50 cells/mm3 or more.

Exclusion Criteria

You will not be eligible for this study if you:

  • Are diagnosed with hepatitis within 30 days prior to study entry.
  • Have certain serious medical conditions, including an AIDS-defining clinical condition.
  • Received chemotherapy or radiation therapy within 30 days of study entry.
  • Have taken any nucleoside reverse transcriptase inhibitors (NRTIs) for more than 2 weeks.
  • Have ever taken 3TC.
  • Have ever taken any non-nucleoside reverse transcriptase inhibitors (NNRTIs).
  • Have taken medications that affect your immune system within 30 days prior to study entry.
  • Have received a vaccine within 30 days prior to study entry.
  • Are enrolled in another anti-HIV drug study while participating in this study.
  • Abuse alcohol or drugs.
  • Are pregnant or breast-feeding.
Gender Both
Ages 13 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00002234
Organization ID 232J
Secondary IDs †† ICC 604
Study Sponsor  Gilead Sciences
Collaborators †† Bristol-Myers Squibb
Glaxo Wellcome
Dupont Pharmaceuticals
Investigators 
Information Provided By Bristol-Myers Squibb
Verification Date November 2004
First Received Date  November 2, 1999
Last Updated Date

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




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