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

Primary Purpose

HIV

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
HAART
HAART + Immunotherapy
Sponsored by
Juan A. Arnaiz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hospital Clinic de Barcelona

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

HAART

HAART + Immunotherapy

Arm Description

Patients assigned to this arm will receive standard HAART

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Adherence to treatment
CD4, CD8
Specific HIV immune responses (CD4 and CTL)
Proportion of patients PVL (plasma viral load)<40
Adverse events

Full Information

First Posted
September 16, 2009
Last Updated
November 18, 2014
Sponsor
Juan A. Arnaiz
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1. Study Identification

Unique Protocol Identification Number
NCT00979706
Brief Title
Immune-based Therapy Pilot Study for the Treatment of Primary HIV Infection (PHI-IMD).
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Juan A. Arnaiz

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HAART
Arm Type
Active Comparator
Arm Description
Patients assigned to this arm will receive standard HAART
Arm Title
HAART + Immunotherapy
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
HAART
Other Intervention Name(s)
Viread, Epivir, Kaletra
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
HAART + Immunotherapy
Other Intervention Name(s)
Cyclosporine A, GM-CSF, Peg-IFN, Interleukin-2
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of patients remaining below 5,000 copies/mL at 12 and 48 weeks after stoping HAART.
Time Frame
W12 y W48
Secondary Outcome Measure Information:
Title
Adherence to treatment
Time Frame
W8, W24, W36, W96
Title
CD4, CD8
Time Frame
W8, W24, W36, W96
Title
Specific HIV immune responses (CD4 and CTL)
Time Frame
W8, W24, W36, W96
Title
Proportion of patients PVL (plasma viral load)<40
Time Frame
W8, W24, W36, W96
Title
Adverse events
Time Frame
W8, W24, W36, W96

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HIV-infected patients (age 18 years or over) with primary HIV infection <90 days. Giving written informed consent to participate into the study. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josep Maria Miró, MDPhD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
27999018
Citation
Nicolas D, Ambrosioni J, Sued O, Brunet M, Lopez-Dieguez M, Manzardo C, Aguero F, Tuset M, Plana M, Guardo AC, Mosquera MM, Munoz-Fernandez MA, Caballero M, Marcos MA, Gatell JM, de Lazzari E, Gallart T, Miro JM. Cyclosporine A in addition to standard ART during primary HIV-1 infection: pilot randomized clinical trial. J Antimicrob Chemother. 2017 Mar 1;72(3):829-836. doi: 10.1093/jac/dkw462.
Results Reference
derived

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

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