Comparing FTC and Lamivudine in HIV-Infected Patients on a Stable Anti-HIV Drug Combination

Completed · Phase 3

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002416

Run by

Triangle Pharmaceuticals

People needed

390

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.)

You may not qualify if…

• 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.

Where it is running

• Dr Robert Wallace — St. Petersburg, Florida, United States
• North Shore Univ Hosp — Great Neck, New York, United States

Full record on ClinicalTrials.gov

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