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Completed

NCT Number: NCT00365612

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

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.

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Key information

Conditions

HIV Infections Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ponce, Puerto Rico

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • A PI (with or without ritonavir) + at least 2 NRTIs or
  • 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.

Treatment and study plan

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

Drug

Primary outcomes

  1. Primary: Proportion of patients with HIV-1 RNA levels <200 copies/mL at Week 48

  2. Safety Outcome Measures: Adverse Events, Laboratory Tests

  3. Outcomes Research Measures: Quality of life, adherence, preference of medication, perceived ease of regimen, HIV symptoms

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

Phase IV, Open-Label, Randomized, Multicenter Study Evaluating Efficacy and Tolerability of Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir DF Compared to Unmodified HAART in HIV-1 Infected Subjects Who Have Achieved Virological Suppression on Their HAART Regimen

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Aug 17, 2006
Registry last updated
Apr 10, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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