Single Tablet Regimen (STR) Simplification Study for HIV-1 Infected Patients

Gilead Sciences

Status and phase

Completed

Phase 4

Conditions

HIV Infections

Treatments

Drug: Efavirenz (EFV), Emtricitabine (FTC), Tenofovir DF (TDF)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00365612

AI266073

Details and patient eligibility

About

To compare the effectiveness (efficacy, safety & tolerability) of a Single Tablet Regimen of efavirenz/emtricitabine/tenofovir DF to subjects continuing on unmodified HAART as measured by the proportion of patients who maintain viral load (HIV-1 RNA) <200 copies/mL at Week 48.

Enrollment

300 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

HIV-1 positive patients who have maintained an HIV-1 viral load <200 copies/mL, for at least 3 months.
Patients must be on their first HAART or have documented viral suppression on a PI-based regimen at the time of any prior change in therapy.
HAART must consist of either:
1. A PI (with or without ritonavir) + at least 2 NRTIs or
2. An NNRTI + at least 2 NRTIs.
Negative serum pregnancy test.

Exclusion criteria

Patients who have taken any NNRTI prior to their current therapy.
Patients who have taken a NRTI-only therapy for greater than 7 days prior to their current therapy.
Patients who are currently taking EFV+FTC+TDF.
Patients who have a creatinine clearance of <60 mL/min by Cockcroft-Gault estimation.
Patients who have experienced virologic failure with any previous ARV therapy.
Patients who have documented resistance to any of the study agents at any time in the past.