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

Tracking Information
First Received Date ^ICMJE	September 16, 2009
Last Updated Date	March 30, 2010
Start Date ^ICMJE	March 2005
Estimated Primary Completion Date	August 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 17, 2009)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00979706 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 17, 2009)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	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)
Official Title ^ICMJE	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)
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	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	HIV
Intervention ^ICMJE	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.
Study Arm (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	22
Estimated Completion Date	August 2010
Estimated Primary Completion Date	August 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Spain

Administrative Information
NCT Number ^ICMJE	NCT00979706
Other Study ID Numbers ^ICMJE	PHI-INMUNOMEDIADO, 2005-000587-11
Has Data Monitoring Committee	Yes
Responsible Party	Dr. José Maria Miró, Infectious Diseases. Hospital Clínic of Barcelona
Study Sponsor ^ICMJE	Hospital Clinic of Barcelona
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Hospital Clinic of Barcelona
Verification Date	March 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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