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

Juan A. Arnaiz

Status and phase: Completed; Phase 4

Conditions: HIV

Treatments: Drug: HAART + Immunotherapy; Drug: HAART

Study type: Interventional

Funder types: Other

Identifiers

NCT00979706

PHI-INMUNOMEDIADO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

HAART

Active Comparator group

Description:

Patients assigned to this arm will receive standard HAART

Treatment:

Drug: HAART

HAART + Immunotherapy

Experimental group

Description:

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.

Treatment:

Drug: HAART + Immunotherapy