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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Juan A. Arnaiz, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00979706
First received: September 16, 2009
Last updated: November 18, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention Phase
HIV
Drug: HAART
Drug: HAART + Immunotherapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Proportion of patients remaining below 5,000 copies/mL at 12 and 48 weeks after stoping HAART. [ Time Frame: W12 y W48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adherence to treatment [ Time Frame: W8, W24, W36, W96 ] [ Designated as safety issue: Yes ]
  • CD4, CD8 [ Time Frame: W8, W24, W36, W96 ] [ Designated as safety issue: Yes ]
  • Specific HIV immune responses (CD4 and CTL) [ Time Frame: W8, W24, W36, W96 ] [ Designated as safety issue: Yes ]
  • Proportion of patients PVL (plasma viral load)<40 [ Time Frame: W8, W24, W36, W96 ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: W8, W24, W36, W96 ] [ Designated as safety issue: Yes ]

Enrollment: 22
Study Start Date: March 2005
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: HAART
Patients assigned to this arm will receive standard HAART
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.

Other Names:
  • Viread
  • Epivir
  • Kaletra
Experimental: HAART + Immunotherapy
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

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.

Other Names:
  • Cyclosporine A
  • GM-CSF
  • Peg-IFN
  • Interleukin-2

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00979706

Locations
Spain
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Sponsors and Collaborators
Juan A. Arnaiz
Investigators
Principal Investigator: Josep Maria Miró, MDPhD Hospital Clinic of Barcelona
  More Information

No publications provided

Responsible Party: Juan A. Arnaiz, MDPhD, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT00979706     History of Changes
Other Study ID Numbers: PHI-INMUNOMEDIADO
Study First Received: September 16, 2009
Last Updated: November 18, 2014
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Cyclosporine
Cyclosporins
Anti-Infective Agents
Antifungal Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014