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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)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Hospital Clinic of Barcelona.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00979706
First received: September 16, 2009
Last updated: March 30, 2010
Last verified: March 2010
History of Changes
  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 + cyclosporin
 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:

U.S. FDA Resources

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
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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 + cyclosporin
Patients assigned to this arm will receive HAART plus cyclosporin A during the first two months.
 Drug: HAART + cyclosporin

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

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

Locations
Spain
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
  More Information

No publications provided

Responsible Party: Dr. José Maria Miró, Infectious Diseases. Hospital Clínic of Barcelona
ClinicalTrials.gov Identifier: NCT00979706     History of Changes
Other Study ID Numbers: PHI-INMUNOMEDIADO, 2005-000587-11
Study First Received: September 16, 2009
Last Updated: March 30, 2010
Health Authority: Spain: Spanish Agency of Medicines

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

ClinicalTrials.gov processed this record on May 19, 2013