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

Phase 1

• Conditions: Human immunodeficiency virus (HIV-1) infection; MedDRA version: 7.0Level: PTClassification code 10020161

• Registration Number: EUCTR2004-002254-59-GB
• Lead Sponsor: Gilead Sciences Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-02-24
• Study Completion: 2007-06-25
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 220

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 < 50 copies/ml on last 2 consecutive tests and < 400 copies/ml for > 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

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 <60ml/min
7) Patients with a Karnofsky score <50
8) Patients with a prior history of significant renal disease
9) Patients with a prior history of osteopenia / osteoporosis
10) Patients who have had a blood transfusion in last 6 weeks
11) Patients with AST / ALT > 5 x ULN

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified