SWEET: Once Daily Truvada Versus Twice Daily Combivir for the Treatment of HIV Infection
Information provided by (Responsible Party)
First received: May 5, 2006
Last updated: June 30, 2008
Last Verified: June 2008
History of Changes
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.
Drug : zidovudine and lamivudine (Combivir®)
Drug : emtricitabine and tenofovir DF
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||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|
Further study details as provided by Gilead Sciences:
Primary Outcome Measures
- The primary endpoint for the study is a change from baseline in absolute haemoglobin at Week 24.
- 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])
- Changes in markers of body composition from dual energy x-ray absorptiometry (DEXA) scans (a sub-study)
- HIV RNA: proportion of patients with HIV ribonucleic acid (RNA) < 400 copies/mL; proportion of patients with HIV RNA < 50 copies/mL and change from baseline in log10 copies/mL at Weeks 24 and 48
- CD4: change from baseline in CD4 counts
- Treatment adherence and acceptability
- Use of lipid lowering drugs (number of patients and duration of use)
- Adverse events (AEs): AEs will be coded and the coded terms will be used to summarize the count of patients with any event, intensity of each event (highest intensity will be used if an event is reported more than once by a patient) and relationship to:
- Other lab tests: results at baseline and changes from baseline
|Study Start Date:||October 2004|
|Study Completion Date:||October 2007|
|Primary Completion Date:||June 2007 (Final data collection date for primary outcome measure)|
The success of HAART is largely dependant on an individual's ability to adhere strictly to an antiretroviral regimen. Regimen characteristics that affect adherence include dosing frequency and pill burden. Several studies have shown improved adherence with lower pill burden and a meta-analysis of the virological outcome in relation to pill burden has shown a significant correlation between lower pill burden and better virological outcome. A systematic review of studies across a range of medical specialties demonstrated that once daily therapy improves adherence relative to more frequent dosing although statistical significance was not demonstrated relative to twice daily regimens.Eligibility
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- Nephrotoxic agents
- Systemic chemotherapeutic agents (i.e. cancer treatment medications)
- Systemic corticosteroids
- Interleukin 2 (IL 2)
- Drugs that interact with efavirenz
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00323544
Locations Show More
|Cambridge, United Kingdom, CB1 6GT|
Sponsors and CollaboratorsGilead Sciences
|Study Director:||Claudio Avila, MD||Gilead Sciences, Ltd.|
|Responsible Party:||Cham Herath, Gilead Sciences|
|ClinicalTrials.gov Identifier:||NCT00323544 History of Changes|
|Other Study ID Numbers:||GS-MC-164-0111|
|Study First Received:||May 5, 2006|
|Last Updated:||June 30, 2008|
Keywords provided by Gilead Sciences:HIV 1
HIV 1 infection
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Lamivudine, zidovudine drug combination
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
ClinicalTrials.gov processed this data on October 20, 2017
This information is provided by ClinicalTrials.gov.