- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002416
Comparing FTC and Lamivudine in HIV-Infected Patients on a Stable Anti-HIV Drug Combination
June 23, 2005 updated by: Triangle Pharmaceuticals
A Randomized, Open-Label Equivalence Study of FTC Versus Lamivudine in Patients on a Stable Triple Antiretroviral Therapy Regimen Containing Lamivudine, Stavudine or Zidovudine, and a Protease Inhibitor or Non-Nucleoside Reverse Transcriptase Inhibitor
The purpose of this study is to compare two anti-HIV drugs, FTC and lamivudine (3TC), when given with either stavudine (d4T) or zidovudine (ZDV) and one other anti-HIV drug.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Patients are randomized to one of two arms in a 2:1 ratio (weighted to Arm 1).
Arm 1: Replace lamivudine with FTC while continuing on current background regimen.
Arm 2: Continue on current lamivudine-containing regimen.
Patients are further stratified based upon screening plasma HIV-1 RNA and background therapy.
Stratum 1: Less than 50 copies/ml; PI (protease inhibitor) in treatment regimen.
Stratum 2: Less than 50 copies/ml; NNRTI (nonnucleoside reverse transcriptase inhibitor) in treatment regimen.
Stratum 3: 50-400 copies/ml; PI in treatment regimen.
Stratum 4: 50-400 copies/ml; NNRTI in treatment regimen.
Clinic visits occur at regular intervals throughout the 48-week study period to determine viral load.
Study Type
Interventional
Enrollment
390
Phase
- Phase 3
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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Florida
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St. Petersburg, Florida, United States, 33713
- Dr Robert Wallace
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New York
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Great Neck, New York, United States, 11021
- North Shore Univ Hosp
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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
18 years and older (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 at least 18 years old.
- Are HIV-positive.
- Have a viral load below 400 copies/ml.
- Agree to use a barrier method of birth control (such as condoms) during the study.
- Have taken one of the following anti-HIV drug combinations: (1) 3TC plus d4T or ZDV plus a protease inhibitor (PI) for at least 8 weeks, or (2) 3TC plus d4T or ZDV plus a nonnucleoside reverse transcriptase inhibitor (NNRTI) for at least 12 weeks. (You must show the date you started on this combination.)
Exclusion Criteria
You will not be eligible for this study if you:
- Have had severe diarrhea or have been unable to eat as much as you need due to nausea, vomiting, or stomachache within 30 days of study entry.
- Have had a serious medical event within 30 days prior to study entry.
- Are taking hydroxyurea.
- Have Grade 2 or higher peripheral neuropathy.
- 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
Investigators
- Study Chair: Charles van der Horst
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
November 2, 1999
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
March 1, 2000
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV 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
- Emtricitabine
- Lamivudine
Other Study ID Numbers
- 298A
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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