Combination of Efavirenz and Truvada - COMET Study
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00224458 |
Recruitment Status
:
Completed
First Posted
: September 23, 2005
Last Update Posted
: April 10, 2008
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Truvada Drug: efavirenz | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 400 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (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. |
Study Start Date : | September 2004 |
Actual Study Completion Date : | February 2006 |

- 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)

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00224458
Study Director: | John Flaherty, PharmD | Gilead Sciences |
Additional Information:
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 |
First Posted: | September 23, 2005 Key Record Dates |
Last Update Posted: | April 10, 2008 |
Last Verified: | February 2008 |
Keywords provided by Gilead Sciences:
Treatment Experienced HIV-1 |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Efavirenz Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 Enzyme Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP3A Inducers Anti-HIV Agents |