Trials / Completed
CompletedNCT02118168
Observational Study for the Extended Follow-up of the Patients Enrolled in the Therapeutic Clinical Trial ISS T-002
OBSERVATIONAL STUDY FOR THE EXTENDED FOLLOW-UP OF THE PATIENTS ENROLLED IN THE PHASE II THERAPEUTIC CLINICAL TRIAL ISS T-002
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 93 (actual)
- Sponsor
- Barbara Ensoli, MD, PhD · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | No intervention | No intervention is foreseen in this Observational Study |
Timeline
- Start date
- 2013-09-01
- Primary completion
- 2016-07-01
- Completion
- 2016-12-01
- First posted
- 2014-04-21
- Last updated
- 2017-08-22
Locations
8 sites across 1 country: Italy
Source: ClinicalTrials.gov record NCT02118168. Inclusion in this directory is not an endorsement.