Study of Three NNNRTI-Sparing Antiretroviral Regimens for Treatment-Naive HIV-1-Infected Volunteers (ACTG A5257)
Location(s): Puerto Rico
The U.S. Department of Health and Human Services (HHS) guidelines recommend that HIV infected patients who have never received anti-HIV therapy be treated with a triple drug regimen. The most commonly prescribed and successful regimen contains the medication efavirenz (EFV). However, this regimen has been shown to cause undesirable side effects for some patients and is therefore not an option. Alternative regimens are needed for these patients.
This study will look at how well different combinations of anti-HIV drugs work to decrease the amount of HIV in the blood (viral load) of and allow immune system recovery in people who have never received anti-HIV therapy. This study will also examine drug tolerability and safety for the various drug combinations.
Of the five anti-HIV drug classes, three are recommended as first-line regimens for patients who have never received anti-HIV treatment before (treatment naive): nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), and protease inhibitors (PIs). The U.S. Department of Health and Human Services (HHS) guidelines recommend that treatment-naive HIV infected patients be treated with a triple drug regimen that includes 2 NRTIs + 1 NNRTI or 2 NRTIs + 1 PI as their initial treatment regimen.
According to data, an efavirenz (EFV)-containing regimen (2 NRTIs + 1 NNRTI, with EFVas the NNRTI) requires fewer pills for the patient, has mild and few side effects, and is more effective in reducing viral load than other regimens, making it the preferred choice for most patients. However, for some patients, an EFV-containing regimen is not possible due to dangerous side effects, acquired NNRTI-resistant HIV virus, or other undesirable effects. For these patients, it is necessary to find alternative regimens with comparable safety and efficacy. This study will examine how well different combinations of anti-HIV drugs work, including safety and drug tolerability for various combinations.
This is a phase III, prospective, randomized study. Participants will be randomly assigned to one of three different groups (treatment arms)—A, B, or C —each representing a different drug combination regimen, none of which will contain an NNRTI.
Arm A: Atazanavir (ATV) + Ritonavir (RTV) + Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF)
Arm B: Raltegravir (RAL) + FTC/TDF
Arm C: Darunavir (DRV) + RTV + FTC/TDF