SWEET: Once Daily Truvada Versus Twice Daily Combivir for the Treatment of HIV Infection

NCT00323544 | Completed Phase 3

• 1 other identifier: GS-MC-164-0111
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate whether the simplified regimen of a once daily fixed dose combination of Truvada (emtricitabine and tenofovir disoproxil fumarate \[DF\]) will be associated with a reduced rate of adverse events, seen with long term use of antiretrovirals, as well as improved adherence compared to a twice daily fixed dose combination of Combivir.

Conditions

HIV Infections

Keywords

HIV 1; HIV 1 infection

Outcome Measures

Primary Outcomes (1)

• The primary endpoint for the study is a change from baseline in absolute haemoglobin at Week 24.

Secondary Outcomes (12)

• The secondary endpoints in this study include: Change from baseline in absolute haemoglobin at Week 48

• Lipids profile: change from baseline in total cholesterol (TC), low density lipoprotein (LDL), high density lipoprotein (HDL), TC/HDL, and triglyceride (TG)

• Quality of life (QoL)

• Measures of treatment adherence (Medication Adherence Self-Report Survey [MASRI] questionnaire)

• Measures of regimen intrusiveness (HIS and Brief Medication Questionnaire [BMQ])

Interventions

zidovudine and lamivudine (Combivir®) DRUG

emtricitabine and tenofovir DF DRUG

Eligibility Criteria

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

You may qualify if:

• Patients of either sex aged \> 18 years.
• HIV positive.
• Stable antiretroviral therapy consisting of efavirenz (EFV) given with Combivir® or zidovudine (AZT) + lamivudine (3TC) for at least 6 months.
• Patients with viral loads \< 50 copies/ml on last 2 consecutive tests and \< 400 copies/ml for \> 3 months.
• Patients requiring a lipid lowering agent must be established on a stable dose/frequency for at least 12 weeks prior to Baseline and be expected to continue on stable dose/frequency for the duration of the study.
• 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 treatment and for 30 days following study drug completion.
• The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.

You may not qualify if:

• Pregnant or lactating female.
• History of AZT monotherapy.
• Use of anabolic steroids, with the exception of testosterone for documented hypogonadism, within 90 days prior to the Baseline visit.
• Documented parvovirus infection.
• Use of erythropoietin within the last six weeks.
• Patients who have had a blood transfusion in the last six weeks.
• Karnofsky score \< 50.
• Prior history of significant renal disease.
• Prior history of osteopenia/osteoporosis.
• Creatinine clearance \< 60mL/min.
• AST/ALT \> 5 x upper limits of normal (ULN).
• Previous adefovir dipivoxil or cidofovir therapy.
• Known history of resistance (including primary resistance) to any of the study medications - tenofovir disoproxil fumarate (TDF), emtricitabine (FTC), AZT, 3TC, or EFV.
• Patients receiving ongoing 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

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (1)

Gilead Sciences

Cambridge, CB1 6GT, United Kingdom

Location

Related Publications (1)

• Fisher M, Moyle GJ, Shahmanesh M, Orkin C, Kingston M, Wilkins E, Ewan J, Liu H, Ebrahimi R, Reilly G; SWEET (Simplification With Easier Emtricitabine Tenofovir) group UK. A randomized comparative trial of continued zidovudine/lamivudine or replacement with tenofovir disoproxil fumarate/emtricitabine in efavirenz-treated HIV-1-infected individuals. J Acquir Immune Defic Syndr. 2009 Aug 15;51(5):562-8. doi: 10.1097/QAI.0b013e3181ae2eb9.

  PMID: 19561519 DERIVED

Related Links

• Study Results

MeSH Terms

Conditions

HIV Infections

Interventions

Zidovudine; Lamivudine; lamivudine, zidovudine drug combination; Emtricitabine; Tenofovir

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)

Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Zalcitabine; Deoxycytidine; Cytidine; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Claudio Avila, MD

  Gilead Sciences, Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 5, 2006
• First Posted: May 9, 2006
• Study Start: October 1, 2004
• Primary Completion: June 1, 2007
• Study Completion: October 1, 2007
• Last Updated: July 4, 2008

Record last verified: 2008-06

Locations

GB (1)