Comparing FTC and Lamivudine in HIV-Infected Patients on a Stable Anti-HIV Drug Combination
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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.
Condition or disease
Drug: EmtricitabineDrug: Lamivudine
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.
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
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
You may be eligible for this study if you:
Are at least 18 years old.
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.)
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.