Combination of Efavirenz and Truvada - COMET Study
Information source: Gilead Sciences
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Truvada (Drug); efavirenz (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Gilead Sciences Official(s) and/or principal investigator(s):
John Flaherty, PharmD, Study Director, Affiliation: Gilead Sciences
Summary
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.
Clinical Details
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.
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: 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)
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Gilead Website Truvada Website Study Results
Starting date: September 2004
Ending date: February 2006
Last updated: April 7, 2008
|
