- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002234
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
June 23, 2005 updated by: Gilead Sciences
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment
25
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Beverly Hills, California, United States, 90211
- Pacific Oaks Med Group
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Colorado
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Denver, Colorado, United States, 80262
- Univ of Colorado / Health Science Ctr
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Georgia
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Atlanta, Georgia, United States, 30308
- AIDS Research Consortium of Atlanta
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Rhode Island
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Providence, Rhode Island, United States, 02908
- Brown Univ School of Medicine
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Virginia
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Hampton, Virginia, United States, 23666
- Hampton Roads Med Specialists
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
August 30, 2001
First Submitted That Met QC Criteria
August 30, 2001
First Posted (Estimate)
August 31, 2001
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
November 1, 2004
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antimetabolites
- Cytochrome P-450 Enzyme Inhibitors
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- Cytochrome P-450 CYP2B6 Inducers
- Cytochrome P-450 CYP2C9 Inhibitors
- Cytochrome P-450 CYP2C19 Inhibitors
- Lamivudine
- Didanosine
- Efavirenz
- Adefovir
- Adefovir dipivoxil
Other Study ID Numbers
- 232J
- ICC 604
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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