Clinical Studies

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Special Features
Advances/Research

Summary:
INCB 8721 RVT-203;A Placebo-Controlled, Double-Blind, Parallel Dose Group Study Exploring the Safety, Tolerability, and Virological Effect of 50, 100, and 200 mg Reversettm (RVT, an NRTI) in HIV-Infected Antiretroviral Therapy-Experienced Subjects when used in Combination with Other Antiretroviral Agents

This is a study of Reverset (RVT), an experimental NRTI (Nucleoside Reverse Transcriptase Inhibitor) to determine the most appropriate dose that is both safe and effective.

Study Design:

Participants will be randomized (like flipping a coin) to one of four study groups:
1. RVT 50 mg once daily
2. RVT 100 mg once daily
3. RVT 200 mg once daily
4. RVT placebo once daily
Prior to randomization to one of the four study groups, the local research team will decide whether the participant's current HAART regimen can be optimized based on the genotype test that was drawn at study screening and the list of anti-HIV medications taken by the participant in the past. If the research team believes an anti-HIV medication regimen more effective than the current one can be constructed, the new regimen should be started 2 weeks after RVT is begun. Sixteen weeks after entry, those participants receiving placebo will begin either 100 or 200 mg RVT once daily and continue that dose until study closure at week 24.

Criteria for Participation:

• HIV viral load greater than 2000
• Currently taking an anti-HIV medication regimen for greater than 60 days
  

Compensation:

Transportation reimbursement provided.