Combination of Efavirenz and Truvada - COMET Study

NCT00224458 | Completed Phase 4

• 1 other identifier: GS-US-164-0107
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

HIV Infections

Keywords

Treatment Experienced; HIV-1

Outcome Measures

Primary Outcomes (1)

• 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)

Interventions

Truvada DRUG

efavirenz DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Gilead Sciences: lead

Related Publications (1)

• DeJesus E, Ruane P, McDonald C, Garcia F, Sharma S, Corales R, Ravishankar J, Khanlou H, Shamblaw D, Ecker J, Ebrahimi R, Flaherty J; COMET Study Team. Impact of switching virologically suppressed, HIV-1-infected patients from twice-daily fixed-dose zidovudine/lamivudine to once-daily fixed-dose tenofovir disoproxil fumarate/emtricitabine. HIV Clin Trials. 2008 Mar-Apr;9(2):103-14. doi: 10.1310/hct0902-103.

  PMID: 18474495 DERIVED

Related Links

• Gilead Website
• Truvada Website
• Study Results

MeSH Terms

Conditions

HIV Infections

Interventions

Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; efavirenz

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Tenofovir; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Study Officials

• John Flaherty, PharmD

  Gilead Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 19, 2005
• First Posted: September 23, 2005
• Study Start: September 1, 2004
• Study Completion: February 1, 2006
• Last Updated: April 10, 2008

Record last verified: 2008-02