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

September 16, 2009
March 30, 2010
March 2005
August 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00979706 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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)
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)

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV
  • 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
  • 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.

  • Active Comparator: HAART
    Intervention: Drug: HAART
  • Experimental: HAART + cyclosporin
    Patients assigned to this arm will receive HAART plus cyclosporin A during the first two months.
    Intervention: Drug: HAART + cyclosporin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
22
August 2010
August 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00979706
PHI-INMUNOMEDIADO, 2005-000587-11
Yes
Dr. José Maria Miró, Infectious Diseases. Hospital Clínic of Barcelona
Hospital Clinic of Barcelona
Not Provided
Not Provided
Hospital Clinic of Barcelona
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP