Back to resultsSafety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Efavirenz
Adefovir dipivoxil
Lamivudine
Didanosine
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, Reverse Transcriptase Inhibitors, Anti-HIV Agents
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.
Sites / Locations
- Pacific Oaks Med Group
- Univ of Colorado / Health Science Ctr
- AIDS Research Consortium of Atlanta
- Brown Univ School of Medicine
- Hampton Roads Med Specialists
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00002234
First Posted
August 30, 2001
Last Updated
June 23, 2005
Sponsor
Gilead Sciences
Collaborators
Bristol-Myers Squibb, Glaxo Wellcome, Dupont Applied Biosciences
1. Study Identification
Unique Protocol Identification Number
NCT00002234
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2004
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Gilead Sciences
Collaborators
Bristol-Myers Squibb, Glaxo Wellcome, Dupont Applied Biosciences
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Drug Therapy, Combination, Reverse Transcriptase Inhibitors, Anti-HIV Agents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
25 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Efavirenz
Intervention Type
Drug
Intervention Name(s)
Adefovir dipivoxil
Intervention Type
Drug
Intervention Name(s)
Lamivudine
Intervention Type
Drug
Intervention Name(s)
Didanosine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Pacific Oaks Med Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Univ of Colorado / Health Science Ctr
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
AIDS Research Consortium of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Brown Univ School of Medicine
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908
Country
United States
Facility Name
Hampton Roads Med Specialists
City
Hampton
State/Province
Virginia
ZIP/Postal Code
23666
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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
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