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Study of the Influence of Vaccination in HIV Viral Load and Immunologic Responses Against HIV

NCT ID: NCT00329251

Last Updated: 2006-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2006-03-31

Brief Summary

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The purpose of this study is to determine whether an immunization schedule is beneficial to HIV-infected patients with CD4 recount over 500 cells/mm3 and undetectable viral load.

Detailed Description

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As HIV-infected patients are considered immunocompromised, it is generally recommended that they have to receipt appropriate vaccines. However data are conflicting concerning potential harmful effects following the administration of commercial vaccines in HIV-infected patients. Transient increases ("blips") in the viral load have been described associated with a single dose of vaccine, with the potential risk of developing resistance to HAART. On the other hand, there has been described that patients with blips can have an increase in HIV-specific immune responses, which may help to improve the viral control.

Comparison: We have performed a clinical trial to evaluate the effect of a vaccination program in successfully treated HIV-infected adults on HAART compared to placebo.

Conditions

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HIV

Keywords

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HIV Viral load Vaccines Immunotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Hepatitis A

Intervention Type BIOLOGICAL

Hepatitis B

Intervention Type BIOLOGICAL

Influenza

Intervention Type BIOLOGICAL

Pneumococcal

Intervention Type BIOLOGICAL

Tetanus-diphteria

Intervention Type BIOLOGICAL

Varicella

Intervention Type BIOLOGICAL

Measles-Mumps-Rubella

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Age \>18 years
* Asymptomatic HIV infection
* CD4\>500/mm3 \>6 months prior to inclusion
* CD4 nadir \>300/mm3
* Being under HAART \> 1 year prior to inclusion
* Viral load\<200 copies/mL \> 6 months prior to inclusion
* Viral load previous to treatment \>5000 copies/mL
* Informed consent

Exclusion Criteria

* Pregnant women
* Basal creatinine \>2.5 mg/dL
* Allergy to either a vaccine or a ingredient of it
* Chronic hepatitis B
* GOT/GPT \> 250 IU/L
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Clinic of Barcelona

OTHER

Sponsor Role lead

Principal Investigators

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José Mª Gatell, MD

Role: STUDY_CHAIR

Hospital Clínic of Barcelona

José Mª Miró, MD

Role: STUDY_CHAIR

Hospital Clínic of Barcelona

José Mª Bayas, MD

Role: STUDY_CHAIR

Hospital Clínic of Barcelona

Locations

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Department of Infectious Diseases, Hospital Clínic, C/Villarroel 170

Barcelona, Barcelona, Spain

Site Status

Countries

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Spain

References

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Yek C, Gianella S, Plana M, Castro P, Scheffler K, Garcia F, Massanella M, Smith DM. Standard vaccines increase HIV-1 transcription during antiretroviral therapy. AIDS. 2016 Sep 24;30(15):2289-98. doi: 10.1097/QAD.0000000000001201.

Reference Type DERIVED
PMID: 27427877 (View on PubMed)

Castro P, Torres B, Lopez A, Gonzalez R, Vilella A, Nicolas JM, Gallart T, Pumarola T, Sanchez M, Leal M, Vallejo A, Bayas JM, Gatell JM, Plana M, Garcia F. Effects of different antigenic stimuli on thymic function and interleukin-7/CD127 system in patients with chronic HIV infection. J Acquir Immune Defic Syndr. 2014 Aug 15;66(5):466-72. doi: 10.1097/QAI.0000000000000207.

Reference Type DERIVED
PMID: 24820104 (View on PubMed)

Castro P, Plana M, Gonzalez R, Lopez A, Vilella A, Nicolas JM, Gallart T, Pumarola T, Bayas JM, Gatell JM, Garcia F. Influence of episodes of intermittent viremia ("blips") on immune responses and viral load rebound in successfully treated HIV-infected patients. AIDS Res Hum Retroviruses. 2013 Jan;29(1):68-76. doi: 10.1089/AID.2012.0145. Epub 2012 Dec 16.

Reference Type DERIVED
PMID: 23121249 (View on PubMed)

Other Identifiers

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VAC-01

Identifier Type: -

Identifier Source: secondary_id

02-0490; EARTH-06

Identifier Type: -

Identifier Source: org_study_id