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.