Combination of Efavirenz and Truvada - COMET Study

This study has been completed.
Sponsor:
Information provided by:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00224458
First received: September 19, 2005
Last updated: April 7, 2008
Last verified: February 2008
  Purpose

To characterize the risks (safety and tolerability), effectiveness (continued viral load suppression and CD4 changes), and benefits (safety, tolerability, adherence, general satisfaction with the treatment regimen and QoL), of switching from a Combivir (BID) / efavirenz (QD) regimen to an all QD regimen of Truvada/efavirenz.


Condition Intervention Phase
HIV Infections
Drug: Truvada
Drug: efavirenz
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Combination of Efavirenz & Truvada (COMET Study): Phase 4 Evaluation of Switching Twice Daily Combivir to Once-Daily Regimen Co-Formulated Truvada in Virologically Suppressed HIV Infected Patients Taking Efavirenz.

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • To characterize the risks (safety and tolerability), effectiveness (continued viral load suppression and CD4 changes), and benefits (safety, tolerability, adherence, general satisfaction with the treatment regimen and QoL)

Estimated Enrollment: 400
Study Start Date: September 2004
Study Completion Date: February 2006
Detailed Description:

The objectives of this study are to characterize the risks (safety and tolerability), effectiveness (continued viral load suppression and CD4 changes), and benefits (safety, tolerability, adherence, general satisfaction with the treatment regimen and QoL), of switching from a Combivir (BID) / efavirenz (QD) regimen to an all QD regimen of Truvada/efavirenz.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult (greater than 18 years) male or non-pregnant female HIV-1 infected patients regardless of race or ethnicity.
  • On a stable antiretroviral regimen consisting of efavirenz QD and Combivir BID for greater than 8 weeks.
  • Plasma HIV 1 RNA less than 400 copies/mL (Roche Amplicor HIV 1 Monitor Test Version 1.5 Ultrasensitive method).
  • Currently experiencing adverse clinical or laboratory effects associated with Combivir and/or who might benefit from a simplified, once-daily antiretroviral treatment regimen regardless of Combivir tolerability status.
  • Adequate renal function defined as a calculated creatinine clearance (CLCr) greater than or equal to 50 mL/min according to the Cockcroft-Gault formula:

Male: (140 - age in years) x (wt in kg) divided by 72 x (serum creatinine in mg/dL) = CLCr (mL/min.

Female: (140 - age in years) x(wt in kg) divided by 72 x (serum creatinine in mg/dL) x 0.85 = CLCr (mL/min).

  • Negative serum pregnancy test (females of childbearing potential only).
  • Willingness to use effective contraception (such as barrier or coil methods) by both males and females while on study drug and for 30 days following study drug completion.
  • Life expectancy less than 1 year.
  • The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures.

Exclusion Criteria:

  • A new AIDS defining condition diagnosed (with the exception of CD4 criteria) within 30 days of baseline.
  • Clinically significant laboratory values that would preclude prescribing antiretroviral therapy, in the opinion of the investigator.
  • Receiving on-going therapy with any of the following (administration of any of the following medications must be discontinued at least 30 days prior to the Baseline visit and for the duration of the study period):
  • Nephrotoxic agents (aminoglycoside antibiotics, IV amphotericin B, cidofovir, cisplatin, foscarnet, IV pentamidine, other agents with significant nephrotoxic potential):

    • Adefovir dipivoxil
    • Probenecid
    • Systemic chemotherapeutic agents (i.e., cancer treatment medications)
    • Systemic corticosteroids
    • Interleukin 2 (IL 2)
    • Investigational agents (except upon approval by Gilead).
  • Drugs that interact with efavirenz:

    • dihydroergotamine
    • ergotamine
    • ergonovine
    • methylergonovine
    • midazolam
    • triazolam
    • cisapride
    • rifampin
  • Pregnant or lactating patients.
  • Evidence of a gastrointestinal malabsorption syndrome or chronic nausea or vomiting which may confer an inability to receive an orally administered medication.
  • Current alcohol or substance abuse judged by the investigator to potentially interfere with patient adherence.
  • Malignancy other than cutaneous Kaposi's sarcoma (KS) or basal cell carcinoma. Patients with biopsy-confirmed cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of baseline and are not anticipated to require systemic therapy during the study.
  • Active, serious infections (other than HIV 1 infection) requiring parenteral antibiotic therapy within 15 days prior to screening.
  • Prior history of significant renal or bone disease.
  • Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the dosing requirements.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00224458

Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: John Flaherty, PharmD Gilead Sciences
  More Information

Additional Information:
No publications provided by Gilead Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: John Flaherty, Director, Medical Affairs, Gilead Sciences
ClinicalTrials.gov Identifier: NCT00224458     History of Changes
Other Study ID Numbers: GS-US-164-0107
Study First Received: September 19, 2005
Last Updated: April 7, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
Treatment Experienced
HIV-1

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Efavirenz
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on April 17, 2014