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

NCT00979706 | Completed Phase 4 DMC

• 1 other identifier: PHI-INMUNOMEDIADO
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

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

  W12 y W48

Secondary Outcomes (5)

• Adherence to treatment

  W8, W24, W36, W96

• CD4, CD8

  W8, W24, W36, W96

• Specific HIV immune responses (CD4 and CTL)

  W8, W24, W36, W96

• Proportion of patients PVL (plasma viral load)<40

  W8, W24, W36, W96

• Adverse events

  W8, W24, W36, W96

Study Arms (2)

HAART

ACTIVE COMPARATOR

Patients assigned to this arm will receive standard HAART

Drug: HAART

HAART + Immunotherapy

EXPERIMENTAL

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.

Drug: HAART + Immunotherapy

Interventions

HAART DRUG

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.

Also known as: Viread, Epivir, Kaletra

HAART

HAART + Immunotherapy DRUG

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.

Also known as: Cyclosporine A, GM-CSF, Peg-IFN, Interleukin-2

HAART + Immunotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-infected patients (age 18 years or over) with primary HIV infection \<90 days.
• Giving written informed consent to participate into the study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Juan A. Arnaiz: lead

Study Sites (1)

Hospital Clinic de Barcelona

Barcelona, Barcelona, 08036, Spain

Location

Related Publications (1)

• 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.

  PMID: 27999018 DERIVED

MeSH Terms

Interventions

Antiretroviral Therapy, Highly Active; Tenofovir; Lamivudine; lopinavir-ritonavir drug combination; Immunotherapy; Cyclosporine; Granulocyte-Macrophage Colony-Stimulating Factor; Interleukin-2

Intervention Hierarchy (Ancestors)

Drug Therapy, Combination; Drug Therapy; Therapeutics; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides; Immunomodulation; Biological Therapy; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Proteins; Biological Factors; Interleukins; Lymphokines

Study Officials

• Josep Maria Miró, MDPhD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MDPhD

Study Record Dates

• First Submitted: September 16, 2009
• First Posted: September 18, 2009
• Study Start: March 1, 2005
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: November 19, 2014

Record last verified: 2014-11

Locations

ES (1)