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HIV InfectionsPhase 4NCT00365612

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

A Phase 4 study testing Efavirenz (EFV), Emtricitabine (FTC), Tenofovir DF (TDF) in people with HIV Infections, run by Gilead Sciences at 56 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
HIV Infections
What is being tested?
Efavirenz (EFV), Emtricitabine (FTC), Tenofovir DF (TDF)
How many people
300 participants
Where
56 sitesin 2 countries
Study dates
Jul 2006to Jan 2008
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

56 sites in 2 countries.

56 sites in 2 countries

United States54 sites

  • Study site

    Akron, Ohio, 44304

  • Study site

    Albany, New York, 12208

  • Study site

    Annandale, Virginia, 22003

  • Study site

    Atlanta, Georgia, 30312

  • Study site

    Aurora, Illinois, 60505

  • Study site

    Baltimore, Maryland, 21201

  • Study site

    Berkley, Michigan, 48072

  • Study site

    Beverly Hills, California, 90211

  • Study site

    Boston, Massachusetts, 02030

  • Study site

    Brooklyn, New York, 11203

  • Study site

    Charlotte, North Carolina, 28209

  • Study site

    Chicago, Illinois, 60657

  • Study site

    Dallas, Texas, 75204

  • Study site

    Decatur, Georgia, 30033

  • Study site

    Denver, Colorado, 80220

  • Study site

    Fort Lauderdale, Florida, 33308

  • Study site

    Greenville, North Carolina, 27858

  • Study site

    Grosse Pointe Woods, Michigan, 48236

  • Study site

    Hampton, Virginia, 23666

  • Study site

    Harlingen, Texas, 78550

  • Study site

    Hillsborough, New Jersey, 08844

  • Study site

    Hobson City, Alabama, 36201

  • Study site

    Hollywood, Florida, 33020

  • Study site

    Houston, Texas, 77009

  • Study site

    Indianapolis, Indiana, 46280

  • Study site

    Long Beach, California, 90813

  • Study site

    Los Angeles, California, 90069

  • Study site

    Miami, Florida, 33136

  • Study site

    Minneapolis, Minnesota, 55404

  • Study site

    Mount Vernon, New York, 10550

  • Study site

    New York, New York, 10011

  • Study site

    Newark, New Jersey, 07101

  • Study site

    Newark, New Jersey, 07102

  • Study site

    Norwalk, Connecticut, 06851

  • Study site

    Oakland, California, 94609

  • Study site

    Orlando, Florida, 32803

  • Study site

    Pensacola, Florida, 32504

  • Study site

    Philadelphia, Pennsylvania, 19107

  • Study site

    Phoenix, Arizona, 85006

  • Study site

    Port Saint Lucie, Florida, 34952

  • Study site

    Providence, Rhode Island, 02906

  • Study site

    Rochester, New York, 14604

  • Study site

    Safety Harbor, Florida, 34695

  • Study site

    San Diego, California, 92103

  • Study site

    San Francisco, California, 94114

  • Study site

    Somers Point, New Jersey, 08244

  • Study site

    Spokane, Washington, 99204

  • Study site

    Springfield, Massachusetts, 01107

  • Study site

    St Louis, Missouri, 63139

  • Study site

    Tampa, Florida, 33607

  • Study site

    Tarzana, California, 91356

  • Study site

    Vero Beach, Florida, 32960

  • Study site

    Washington D.C., District of Columbia, 20037

  • Study site

    Winston-Salem, North Carolina, 27157

Other trials in United States

Puerto Rico2 sites

  • Study site

    Ponce, 00731

  • Study site

    San Juan, 00909

Other trials in Puerto Rico

About this study

Official 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

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.

Conditions
HIV Infections
Being tested
Efavirenz (EFV), Emtricitabine (FTC), Tenofovir DF (TDF)
Keywords
HIV, HIV-1, AIDS, Human Immunodeficiency Virus, HIV-1 Infection
Medical subject headings
HIV Infections, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2006 (estimated)
  2. Study startJul 2006
  3. Primary completionOct 2007
  4. Study completionJan 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00365612
Sponsor's protocol ID
AI266073
Status last verified
Apr 2008
First submitted
16 Aug 2006
Last updated
10 Apr 2008
Results posted
No
Data monitoring committee
No

Publications

  • Hodder SL, Mounzer K, Dejesus E, Ebrahimi R, Grimm K, Esker S, Ecker J, Farajallah A, Flaherty JF; AI266073 Study Group. Patient-reported outcomes in virologically suppressed, HIV-1-Infected subjects after switching to a simplified, single-tablet regimen of efavirenz, emtricitabine, and tenofovir DF. AIDS Patient Care STDS. 2010 Feb;24(2):87-96. doi: 10.1089/apc.2009.0259.

    PubMed 20156091

  • Dejesus E, Young B, Morales-Ramirez JO, Sloan L, Ward DJ, Flaherty JF, Ebrahimi R, Maa JF, Reilly K, Ecker J, McColl D, Seekins D, Farajallah A; AI266073 Study Group. Simplification of antiretroviral therapy to a single-tablet regimen consisting of efavirenz, emtricitabine, and tenofovir disoproxil fumarate versus unmodified antiretroviral therapy in virologically suppressed HIV-1-infected patients. J Acquir Immune Defic Syndr. 2009 Jun 1;51(2):163-74. doi: 10.1097/QAI.0b013e3181a572cf.

    PubMed 19357529

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Efavirenz (EFV), Emtricitabine (FTC), Tenofovir DF (TDF) in people with HIV Infections, run by Gilead Sciences at 56 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary: Proportion of patients with HIV-1 RNA levels <200 copies/mL at Week 48. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00365612, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2008.

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Clinical Trial NCT00365612 | AzTrials