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

HIV Clinical Trial

— PHI-IMD  

Official title:

Immune-based Therapy 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 Highly Active Anti-Retroviral Therapy (HAART)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00979706
• Other study ID #: PHI-INMUNOMEDIADO
• Status: Completed
• Phase: Phase 4
• First received: September 16, 2009
• Last updated: November 18, 2014
• Start date: March 2005
• Est. completion date: November 2014

Study information

• Verified date: November 2014
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV
• HIV Infections

Intervention

Drug:
• HAART
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 + Immunotherapy
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.

Locations

Country	Name	City	State
Spain	Hospital Clinic de Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Juan A. Arnaiz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients remaining below 5,000 copies/mL at 12 and 48 weeks after stoping HAART.		W12 y W48	No
Secondary	Adherence to treatment		W8, W24, W36, W96	Yes
Secondary	CD4, CD8		W8, W24, W36, W96	Yes
Secondary	Specific HIV immune responses (CD4 and CTL)		W8, W24, W36, W96	Yes
Secondary	Proportion of patients PVL (plasma viral load)<40		W8, W24, W36, W96	Yes
Secondary	Adverse events		W8, W24, W36, W96	Yes