Status:
COMPLETED
Immune-based Therapy Pilot Study for the Treatment of Primary HIV Infection (PHI-IMD).
Lead Sponsor:
Juan A. Arnaiz
Conditions:
HIV
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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.
Detailed Description
Pilot and open RCT in 20 patients with primary HIV-1 infection who were randomized to one of these two arms: 1) Control arm (A), Tenofovir +Lamivudine + Lopinavir-ritonavir (Kaletra) at standard doses...
Eligibility Criteria
Inclusion
- HIV-infected patients (age 18 years or over) with primary HIV infection \<90 days.
- Giving written informed consent to participate into the study.
Exclusion
- Patients not accepting to start HAART. Patients wishing start HAART treatment with nevirapine or efavirenz.
- Pregnant women or planning pregnancy.
- Intravenous drug user or alcohol abuse.
- Previous treatment with cyclosporin A, GM-CSF,pegylated-interferon-alpha o interleukine-2.
- Renal or liver failure.
- Any formal contraindication to treatment with the study drugs.
- Patients with a history of psychiatric disorder, thyroid illness, dislipidemia requiring treatment, cardiovascular disease, arterial hypertension, or diabetes mellitus.
- In treatment with drugs interacting with study drugs.
- Acute infection for HTLV-I or EBV.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00979706
Start Date
March 1 2005
End Date
November 1 2014
Last Update
November 19 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Clinic de Barcelona
Barcelona, Barcelona, Spain, 08036