Status:
COMPLETED
QoL and Adherence to One-pill Once-a-day HAART
Lead Sponsor:
A.O. Ospedale Papa Giovanni XXIII
Conditions:
HIV Infection
HIV Infections
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
Primary objective of the study is: To verify if simplification of the antiretroviral regimen, measured as the reduction of pill burden alone, may affect adherence rate of patients.
Eligibility Criteria
Inclusion
- Age \> 18 years
- Informed consent signed
- Effective ongoing treatment (HIV-RNA \< 50 copies/ml) for at least three months
- Being on a stable HAART regimen based either on two possible drug associations:
- 3TC/FTC + TDF + EFV
- FTC/TDF (fixed dose combination) + EFV
- No previous documented virologic failure
Exclusion
- Childbearing or breastfeeding. Women of childbearing potential will be asked to adopt effective contraceptive methods or behaviours
- Any ongoing grade 4 laboratory abnormality
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT00990600
Start Date
April 1 2008
End Date
May 1 2009
Last Update
October 29 2009
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