Status:
COMPLETED
Long Term Treatment Interruptions
Lead Sponsor:
A.O. Ospedale Papa Giovanni XXIII
Conditions:
HIV Infections
AIDS
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
LOTTI study Centers This a multicenter, multinational study. Clinical phase: III Objectives The primary objective is to compare efficacy and safety of continuing a conventional HAART in chronicall...
Detailed Description
Rationale As the current regimens cannot eradicate HIV infection, persons living with HIV are doomed to assume chronic therapies with often very demanding daily schedules. In the long run, this may l...
Eligibility Criteria
Inclusion
- Age \> 17 years
- Informed consent signed
- 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.
- Current CD4 cell count above 600 cells/mcL and nadir of CD4 cell count \> 200 cells/mcL
Exclusion
- Childbearing or breastfeeding. Women of childbearing potential will be asked to adopt effective contraceptive methods or behaviors
- 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.
- Previous diagnosis of AIDS
- Patients with HBV coinfection on active anti-HIV treatment with either lamivudine and/or tenofovir
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT00433056
Start Date
January 1 2004
Last Update
April 25 2008
Active Locations (1)
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1
Ospedali Riuniti
Bergamo, BG, Italy, 24128