| 330 FACT SHEET |
| Impact of Raltegravir (Isentress)-Containing Regimens on HIV-1 Infected CD4+ T-Cells During Acute and Early HIV-1 Infection: A Randomized,Controlled Study Comparing Standard Antiretroviral Therapy to Standard Therapy Plus Raltegravir
|
Background:
|
| Raltegravir is an anti-HIV drug approved for treatment of HIV in persons with resistant HIV. It is an integrase inhibitor and works inside cells to prevent HIV from getting into the human cell genetic material (DNA).
|
Purpose of This Trial:
|
| To compare levels of HIV in specific cells (nesting CD4 T-cells) after 96 weeks of treatment with a raltegravir-based antiretroviral regimen versus treatment with standard anti-HIV treatment during and acute and early HIV-1 infection.
|
Requirements to Enter Study: |
- Men and women aged 18 years or older (women must have a negative pregnancy test and be willing to use contraception during the study)
- Acquired HIV-1 infection within the past 6 months
- HIV viral load ≥ 500 copies/mL obtained within 14 days prior to study entry
- No prior HIV treatment (other than post-exposure or pre-exposure prophylaxis)
|
| Study Design: |
Randomized (like flipping a coin) to either:
(1) Standard triple anti-HIV therapy (selected by the study investigators with the subject’s primary care provider). These medications will not be provided by the protocol.
(2) Standard anti-HIV triple therapy (as in group 1) PLUS protocol-provided raltegravir.
|
| Length of Study: |
| Up to 96 weeks.
|
Schedule of Study Appointments (about 1 hour each): |
Screening, entry and weeks ½, 1, 2, 3, 4, 12, 16, 24 and then every 12 weeks thereafter. Visits include physical exams, blood draws, and questionnaires.
|
| Reimbursement: |
| Exams, lab tests, and raltegravir are provided at no cost. Participants will receive $20 per study visit and $250 if they have a leukapheresis (a procedure to collect white blood cells).
|
Contact the University of Washington Primary Infection Clinic at (206) 667-2300 for more information.
|
