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

Completed · Phase 4

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00365612

Run by

Gilead Sciences

People needed

300

Starts

2006-07-01

Expected to finish

2008-01-01

Last updated by the study team

2008-04-10

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• A PI (with or without ritonavir) + at least 2 NRTIs or
• An NNRTI + at least 2 NRTIs.
• Negative serum pregnancy test.

You may not qualify if…

• 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.

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Beverly Hills, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Oakland, California, United States
• Study site — San Diego, California, United States
• Study site — San Francisco, California, United States
• Study site — Tarzana, California, United States
• Study site — Denver, Colorado, United States
• Study site — Norwalk, Connecticut, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Hollywood, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Pensacola, Florida, United States
• Study site — Port Saint Lucie, Florida, United States
• Study site — Safety Harbor, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Vero Beach, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Decatur, Georgia, United States
• Study site — Aurora, Illinois, United States
• Study site — Chicago, Illinois, United States
• Study site — Hobson City, Alabama, United States

Full record on ClinicalTrials.gov

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