A Novel Strategy Study Opens at the ACTU
A5073: A Randomized, Phase II, Open Label Study to Compare Twice-Daily and Once-Daily Potent Antiretroviral Therapy and to Compare Self-Administered Therapy and Therapy Administered Under Direct Observation
The UW AIDS Clinical Trials Unit is enrolling volunteers for a major new treatment strategy trial. The study will look at two different treatment strategies in people who have not taken HIV medications previously. The study will compare once-a-day versus twice-a-day administration of the same drugs, and also compare directly observed therapy (DOT) to self-administration in the group receiving once-daily therapy. The drugs used in this study will be Kaletra, the new, extended-release formulation of Zerit (d4T), and FTC, a new once-a-day NRTI. A total of 375 people will be enrolled nationally on this study.
All participants will be randomized into one of three groups to take anti-HIV medications once or twice a day, and the once-a-day group will be randomized into DOT versus self-administration. Those randomized into the DOT group will be required to visit the clinic every day (Monday through Friday) to receive their medications for the first 24 weeks (or possibly to meet a study nurse at a convenient location). The other participants will self-administer medications and will visit the clinic every 2 weeks for the first 16 weeks of the study, and every 8 weeks thereafter, for a total of 48 weeks. There is a 20 percent probability (a 1 out of 5 chance) of being randomized into the DOT group.
Medications, viral load counts, and CD4 counts are provided by the study. All participants are reimbursed $20 per visit when lab work is done. Participants randomized into the DOT group also get $5 for each day of DOT.
Potential participants need to meet the following criteria: they should be HIV-positive; have no prior use of HIV medications; be at least 13 year of age; have a viral load greater than 2000; have no severe medical conditions or infections; and, if female, not be pregnant or breastfeeding.
For more information, call Alyssa Spingola or Lori Cray at 206-731-3184 or email the ACTU at: email@example.com.
This article was provided by Seattle Treatment Education Project. It is a part of the publication STEP Perspective.