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

Phase 4

Completed

• Conditions: HIV
• Interventions: Drug: HAART + Immunotherapy; Drug: HAART

• Registration Number: NCT00979706
• Lead Sponsor: Juan A. Arnaiz

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 for 44 weeks (W44); a short treatment interruption (TI) was performed at W36, and HAART was restarted for 8 weeks when plasma HIV-1 RNA viral load (pVL) rebounded\>200 copies/mL. At W44 HAART was stopped and patients were followed for 48 additional weeks (W92). 2) Immune-based arm (B), same HAART schedule plus oral cyclosporine A (CsA)(serum levels 250-350 mcg/L) for the first 8 weeks of HAART. During the TI, patients received sc GM-CSF (250 mcg TIW) plus weekly sc pegylated-interferon a2b (Peg-INF)(1.5 mcg/kg/week). During the last 8 weeks of HAART (until W44), patients received daily sc low-dose interleukin-2 (IL-2)(0.75 MU/kg QD). The primary endpoint was pVL \<1000copies/mL (\<3.0 log10/mL) at 12 (W56) and at 48 (W92) weeks after stopping HAART. Sample size was calculated in order to detect a pVL difference of 1.5log10 copies/mL at 12 (W56) weeks after stopping HAART between the control and the immune-based arms with a power of 80% and a level of significance of0.05.

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2009-09-16
• Study First Submitted QC: 2009-09-17
• Study First Posted: 2009-09-18
• Status Verified: 2014-11
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Last Update Submitted: 2014-11-18
• Last Update Posted: 2014-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HAART + Immunotherapy	HAART + Immunotherapy	Patients assigned to this arm will receive HAART plus cyclosporin A during the first two months and after that will receive IFN, GM-CSF and IL-2.
HAART	HAART	Patients assigned to this arm will receive standard HAART

Primary Outcome Measures

Name	Time	Method
Proportion of patients remaining below 5,000 copies/mL at 12 and 48 weeks after stoping HAART.	W12 y W48

Secondary Outcome Measures

Name	Time	Method
Adherence to treatment	W8, W24, W36, W96
CD4, CD8	W8, W24, W36, W96
Specific HIV immune responses (CD4 and CTL)	W8, W24, W36, W96
Adverse events	W8, W24, W36, W96
Proportion of patients PVL (plasma viral load)<40	W8, W24, W36, W96

Trial Locations

Locations (1)

Hospital Clinic de Barcelona; 🇪🇸 Barcelona, Spain