M. Harris AIDS. 2008 Jun 19;22(10):1224-6
Type of ARV Trial
Switch studies in virologically suppressed patients
» Switch to RAL-containing regimen
Switch studies in virologically suppressed patients
» Switch to RAL-containing regimen
Drugs
ENF, RAL
ENF, RAL
- Pilot, open-label study
- 35 adults on salvage therapy with enfuvirtide-based regimen and HIV-1 RNA < 50 c/mL
- Switch of enfuvirtide to RAL 400 mg bid, the remainder of the salvage regimen being unchanged. At the time of the switch:
- ENF had been administered for a median of 25 months
- HIV-1 RNA was < 50 c/mL for a median of 24 months
- Salvage regimen: 1 to 4 NRTIs, 1 NNRTI in 6 patients, 1 to 2 PIs
- Median follow-up of 7 months (range 1-13 months)
- 34/35 patients maintained HIV-1 RNA < 50 c/mL
- 1 single blip at 60 c/mL
- ENF-related injection site reactions resolved in all patients
- RAL was well tolerated