Observational Study for the Extended Follow-up of the Patients Enrolled in the Therapeutic Clinical Trial ISS T-002 (ISST-002 EF-UP)

Barbara Ensoli, MD, PhD

Status: Completed

Conditions: HIV Infection

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT02118168

ISS T-002 EF-UP

Details and patient eligibility

About

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.

Enrollment: 93 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

93 participants in 1 patient group

No treatment

Description:

All patients that participated to the therapeutic phase II trial of the Tat vaccine "ISS T-002" and that received at least 3 immunizations and reached 48-weeks of follow-up.

Treatment:

Other: No intervention