Comparing FTC and Lamivudine in HIV-Infected Patients on a Stable Anti-HIV Drug Combination
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Emtricitabine (Drug); Lamivudine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Triangle Pharmaceuticals Official(s) and/or principal investigator(s):
Charles van der Horst, Study Chair
Summary
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.
Clinical Details
Official title: 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
Study design: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Dr Robert Wallace, St. Petersburg, Florida 33713, United States
North Shore Univ Hosp, Great Neck, New York 11021, United States
Additional Information
Last updated: June 23, 2005
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