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

Juan A. Arnaiz22 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV

Interventions

HAARTDRUG

Patients assigned to this arm will receive Trizivir and kaletra. After the first 9 months of HAART, all patients will stop HAART until HIV viral load in plasma became detectable (\>200 copies/mL). Then, they will re-start HAART plus low doses of IL-2 during 2 months. All patients will be followed-up during 1 year.

HAART + ImmunotherapyDRUG

Patients assigned to this arm will receive Trizivir + Kaletra + cyclosporin A during the first two months. This group also will receive GM-CSF plus pegylated-interferon-alpha until HIV viral load in plasma became detectable (\>200 copies/mL). Then, they will re-start HAART plus low doses of IL-2 during 2 months. At this moment they will stop HAART. All patients will be followed-up during 1 year.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital Clinic de Barcelona

Barcelona, Barcelona, Spain

Outcomes

Primary Outcomes

Proportion of patients remaining below 5,000 copies/mL at 12 and 48 weeks after stoping HAART.

Time frame: W12 y W48

Secondary Outcomes

Adherence to treatment

Time frame: W8, W24, W36, W96

CD4, CD8

Time frame: W8, W24, W36, W96

Specific HIV immune responses (CD4 and CTL)

Time frame: W8, W24, W36, W96

Proportion of patients PVL (plasma viral load)<40

Time frame: W8, W24, W36, W96

Adverse events

Time frame: W8, W24, W36, W96

Data from ClinicalTrials.gov

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