A phase 3, open label, randomised, parallel group study to compare the effect on prevention and resolution of treatment related adverse events of a simplified, once daily regimen of a fixed dose combination tablet of emtricitabine and tenofovir DF versus twice daily co-formulated zidovudine and lamivudine (Combivir®) or zidovudine and lamivudine, in virologically suppressed, HIV infected patients taking efavirenz. - SWEET Study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-002254-59-IE

Enrollment

220

Registered

2005-02-09

Start date

2005-05-06

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human immunodeficiency virus (HIV-1) infection MedDRA version: 7.0 Level: PT Classification code 10020161

Interventions

Trade Name: Truvada Product Name: emtricitabine/tenofovir disoproxil fumarate (fixed dose combination) Pharmaceutical Form: Film-coated tablet INN or Pr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Adult ( > 18 years) male and non-pregnant female HIV-1 infected patients 2) Patients maintained on stable antiretroviral therapy consisting of EFV given with Combivir® or AZT+3TC for at least 6 months 3) Patients with viral loads 3 months 4) 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 at a stable dose/frequency for the duration of the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1) Patients with known resistance (including primary resistance) to any of the study medications – TDF, FTC, AZT, 3TC, EFV 2) Patients co-infected with hepatitis B 3) Patients receiving anabolic steroids 4) Patients receiving ongoing therapy with nephrotoxic agents 5) Patients with history of AZT monotherapy 6) Patients with a Creatinine Clearance of 5 x ULN

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine if switching from Combivir® or AZT +3TC to a fixed-dose tablet of FTC/TDF leads to changes in absolute haemoglobin at 24 weeks.; Secondary Objective: 1) To determine if switching from Combivir® or AZT +3TC to a fixed-dose tablet of FTC/TDF leads to changes in absolute haemoglobin at 48 weeks. 2) To determine whether switching from Combivir® or AZT +3TC to FTC/TDF backbone leads to an improvement in lipid profile or a delay in the time to lipid elevation. 3) To compare the immunological and virological outcomes for patients 4) To determine whether FTC/TDF increases the time to treatment failure by improving virological efficacy, durability and safety compared to Combivir® or AZT +3TC therapy. 5) To assess the effect of using once daily FTC/TDF on adherence and acceptability using the HAART Intrusiveness Scale (HIS) and the Medication Adherence Self-Report Inventory (MASRI) and on quality of life using the SF-12v2 questionnaire. ;Primary end point(s): Change in hemoglobin from baseline to week 24. The two sample t-test will be utilized for the primary analysis to compare the difference between the AZT/3TC and FTC/TDF arms of the study.	—

Measure

Time frame

Main Objective: To determine if switching from Combivir® or AZT +3TC to a fixed-dose tablet of FTC/TDF leads to changes in absolute haemoglobin at 24 weeks.; Secondary Objective: 1) To determine if switching from Combivir® or AZT +3TC to a fixed-dose tablet of FTC/TDF leads to changes in absolute haemoglobin at 48 weeks. 2) To determine whether switching from Combivir® or AZT +3TC to FTC/TDF backbone leads to an improvement in lipid profile or a delay in the time to lipid elevation. 3) To compare the immunological and virological outcomes for patients 4) To determine whether FTC/TDF increases the time to treatment failure by improving virological efficacy, durability and safety compared to Combivir® or AZT +3TC therapy. 5) To assess the effect of using once daily FTC/TDF on adherence and acceptability using the HAART Intrusiveness Scale (HIS) and the Medication Adherence Self-Report Inventory (MASRI) and on quality of life using the SF-12v2 questionnaire. ;Primary end point(s): Change in hemoglobin from baseline to week 24. The two sample t-test will be utilized for the primary analysis to compare the difference between the AZT/3TC and FTC/TDF arms of the study.

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Countries

Ireland, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026