Status:
COMPLETED
BASTA Study on STI in HIV Infected Patients
Lead Sponsor:
A.O. Ospedale Papa Giovanni XXIII
Conditions:
HIV Infection
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
This is a single center, independent study. The primary objective is to compare efficacy and safety of continuing a conventional HAART in chronically infected HIV patients with a therapeutic strategy ...
Detailed Description
Study objectives Primary objective of the study is: To compare efficacy (clinical and immunological) and safety of continuing a conventional HAART in chronically infected HIV patients with a therape...
Eligibility Criteria
Inclusion
- i. Age \> 17 years ii. Informed consent signed iii. Effective ongoing treatment (HIV-RNA \< 50 copies/ml). Treatment must be based on any triple drug therapy. Patients must be on the same steady therapy for at least 3 months.
- iv. Current CD4 cell count above 800 cells/L
Exclusion
- i. Childbearing or breastfeeding. Women of childbearing potential will be asked to adopt effective contraceptive methods or behaviors ii. Any ongoing grade 4 (WHO) AE or laboratory abnormality with the exclusion of cholesterol, triglycerides for which a grade 3 (AHA) level will be considered an exclusion criteria.
- iii. Previous use of immunomodulatory agents
Key Trial Info
Start Date :
November 1 2000
Trial Type :
INTERVENTIONAL
End Date :
November 1 2005
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00310245
Start Date
November 1 2000
End Date
November 1 2005
Last Update
July 24 2006
Active Locations (1)
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1
Antiviral Therapy Unit, Ospedali Riuniti
Bergamo, Bergamo, Italy, 24128