OBSERVATIONAL STUDY FOR THE EXTENDED FOLLOW-UP OF THE PATIENTS ENROLLED IN THE PHASE II THERAPEUTIC CLINICAL TRIAL ISS T-002
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- HIV Infection
- Sponsor
- Barbara Ensoli, MD, PhD
- Enrollment
- 93
- Locations
- 8
- Primary Endpoint
- anti-Tat humoral immune response
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
An observational study to prospectively follow-up the patients enrolled in the ISS T-002 clinical trial up to 132 weeks. The primary endpoint of this study is to evaluate the persistence, in term of frequency, magnitude and quality, of the anti-Tat humoral and cellular immune response in the HIV-1 infected individuals who participated to the ISS T-002 and who have received at least 3 immunizations. The secondary endpoint is to define and validate novel laboratory tests for future efficacy clinical trials.
Investigators
Barbara Ensoli, MD, PhD
PhD
Istituto Superiore di Sanità
Eligibility Criteria
Inclusion Criteria
- •Previous participation in the ISS T-002 trial, having received at least 3 immunizations;
- •A follow-up of at least 48 weeks during the ISS T-002 study;
- •Availability to participate in the extended follow-up study;
- •Signed informed consent.
Exclusion Criteria
- •The absence of any of the above criteria will exclude the subjects from the study.
Outcomes
Primary Outcomes
anti-Tat humoral immune response
Time Frame: Every 3 months, up to 2.5 years
The primary endpoint of the study is to evaluate the persistence, in term of frequency, magnitude, and quality of the anti-Tat humoral immune response in HAART-treated patients previously immunize with Tat in the ISS T-002 phase II clinical trial.
Secondary Outcomes
- Testing of the additional Immunological parameters detailed below as a second line testing(Every 3 months, up to 2.5 years)
- Testing of virological parameters detailed below, as a second line testing(Every 3 months, up to 2.5 years)