Status:
COMPLETED
Intermittent ART in Primary HIV Infection
Lead Sponsor:
Juan A. Arnaiz
Conditions:
HIV
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Interventions during primary HIV infection (PHI) can modify the immune control and the clinical evolution during the chronic phase. Although several studies suggest the benefit of antiretroviral treat...
Detailed Description
The study design included two phases. The first phase consisted in four STI of 8 weeks each (off-ART), separated by 16 weeks of treatment -or the time necessary to reach again to PVL \<20 copies/mL- (...
Eligibility Criteria
Inclusion
- PHI defined by detectable plasma viral load (PVL) or p24 antigen detection coupled with a negative or indeterminate LIA assay (according CDC criteria); negative HIV-1 EIA in the preceding 90 days or by a positive EIA and LIA assay with acute retroviral syndrome in the preceding 90 days of starting ART plus documented negative HIV-1 EIA within the previous year.
- ART started within 90 days from the HIV exposure and continuing in the same treatment at least 12 months before the inclusion, and they must have shown good virological and immunological responses, defined as undetectable PVL (\<20 copies/mL in the last two controls) and CD4 more than 500 cells/mm3 with a CD4/CD8 ratio \>1 in the last 8 months previous to enrolment
Exclusion
- Infection of more than 90 days.
- Age under 18 years old.
- AIDS defining condition
Key Trial Info
Start Date :
March 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02300623
Start Date
March 1 2000
End Date
April 1 2013
Last Update
November 25 2014
Active Locations (1)
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1
Hospital Clinic de Barcelona
Barcelona, Barcelona, Spain, 08036