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Completed

NCT Number: NCT00414635

FOTO: Five Consecutive Days on Treatment With Efavirenz, Tenofovir, and Emtricitabine Followed by Two Days Off Treatment Versus Continuous Treatment

For people with HIV who are currently taking specific medications (including Sustiva (efavirenz)) and have no detectable viral load, this study tracks how patients do if they take their medications for five days of the week compared with seven days of the week.

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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–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CARE-ID, Washington D.C., District of Columbia, United States

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About this study

The purpose of this study is to evaluate virologic control of a weekly schedule of 5 days of treatment followed by two days off treatment versus continuous treatment with the same regimen. This is a larger study based on the results of our successful pilot study using the same protocol. The 48 week, phase IV trial addresses the issues of the high cost of HIV treatment, adherence problems associated with daily treatment, and cumulative toxicities. Virologic and immunologic parameters, drug levels of efavirenz, adherence, and toxicity will be measured. Subjects will have to be seen at CRI for 6 visits after randomization. Subjects randomized to daily therapy will cross over to 5/2 therapy at 24 weeks if their viral load remains undetectable.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18 years or older
  • CD4 count > or = 200
  • Viral load < 50
  • Treatment with a regimen containing efavirenz and tenofovir and lamivudine or emtricitabine for at least 90 days prior to screening

Exclusion criteria

  • Detectable HIV RNA on an ultrasensitive assay within the 90 days preceding screening
  • Prior evidence of intermediate or high level resistance to efavirenz, tenofovir or cytidine analogues
  • Hepatitis B infection

Treatment and study plan

Intermitent Dosing

Drug

Intermittent dosing treatment is the maintenance of the "5/2" schedule, where the regimen, 300 mg tenofovir td, 600 mg efavirenz, 200 mg emtricitabine is dosed for 5 consecutive days - typically Monday through Friday - followed by two days off of medication, 300 mg tenofovir td, 600 mg efavirenz, 200 mg emtricitabine. .

Primary outcomes

  1. Percentage of Participants Who Maintained Virologic Suppression (Less Than 50 RNA Cps/ml)

    Time frame: 24 weeks

    Percentage of Participants maintaining full Virologic Suppression (less than 50 RNA cps/ml)

Secondary outcomes

  1. Mean CD4+ T-cell Count Increases From Baseline to Week 24.

    Time frame: Baseline to Week 24

  2. Quality of Life

    Time frame: 4 weeks

    Participant preference of antiretroviral (ART) regimen determined on a scale ranging from 0 to 10. O was defined as "I Perfer taking HIV medications 7 days/week" and 10 was defined as "I perfer 5 days on and 2 days off". We present results of a single question on quality of life experienced while on their study ART regimen.

  3. Absolute Number of Virological "Blip" Events Occurring Over 24 Weeks

    Time frame: Baseline to week 24

    Total number of "blip" events in each arm. Blips are defined as HIV RNA > 50 and < 200 cps/ml

  4. Trough Blood Levels of Efavirenz in Both Arms

    Time frame: 12 or 60 hours

    blood levels of efavirenz measured at 60 hours post last dose in FOTO arm and 12 hours post last dose in daily arm (control)

  5. Self-reported Adherence Summary in Both Arms

    Time frame: 4, 12 and 24 weeks

    Percentage of participants who missed one or more doses in weekly regimen.

  6. Deviation From FOTO Schedule by One Extra Dose

    Time frame: 4, 12, 24 weeks

    Percentage of FOTO participants who took a dose during weekend planned interuption period

Sponsors and collaborators

Lead sponsor

Community Research Initiative of New England

Other

Collaborators

  • The Campbell Foundation

Registry information

Official study title

A Randomized Controlled Trial of a Weekly Schedule of Five Consecutive Days on Treatment With Efavirenz, Tenofovir, and Emtricitabine Followed by Two Days Off Treatment (5/2 Intermittent Treatment Schedule) Versus Continuous Treatment in Individuals With Virologic Suppression on This Combination

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Dec 21, 2006
Registry last updated
Sep 25, 2017

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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