Overview

Immune-based Therapy Pilot Study for the Treatment of Primary HIV Infection (PHI-IMD).

Status:
Completed
Trial end date:
2014-11-01
Target enrollment:
0
Participant gender:
All
Summary
Pilot study for the treatment of primary HIV infection with the objective to induce a strong specific HIV immune response able to control viral replication without HAART.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Juan A. Arnaiz
Treatments:
Cyclosporine
Cyclosporins
Interleukin-2
Lopinavir
Criteria
Inclusion Criteria:

1. HIV-infected patients (age 18 years or over) with primary HIV infection <90 days.

2. Giving written informed consent to participate into the study.

Exclusion Criteria:

1. Patients not accepting to start HAART. Patients wishing start HAART treatment with
nevirapine or efavirenz.

2. Pregnant women or planning pregnancy.

3. Intravenous drug user or alcohol abuse.

4. Previous treatment with cyclosporin A, GM-CSF,pegylated-interferon-alpha o
interleukine-2.

5. Renal or liver failure.

6. Any formal contraindication to treatment with the study drugs.

7. Patients with a history of psychiatric disorder, thyroid illness, dislipidemia
requiring treatment, cardiovascular disease, arterial hypertension, or diabetes
mellitus.

8. In treatment with drugs interacting with study drugs.

9. Acute infection for HTLV-I or EBV.