Study of the Influence of Vaccination in HIV Viral Load and Immunologic Responses Against HIV
May 22, 2006 updated by: Hospital Clinic of Barcelona
Study of the Influence of Immunological Repeated Stimuli With Commercial Vaccines Over the Viral Load (VL), Resistance Development and Specific Immunological Response Against HIV in Early Stage HIV Patients With Undetectable VL After HAART
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.
Study Overview
Status
Completed
Conditions
Detailed Description
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.
Study Type
Interventional
Enrollment
26
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Barcelona, Spain, 08036
- Department of Infectious Diseases, Hospital Clínic, C/Villarroel 170
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Times viral load increases over 20.000 copies/mL.
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Secondary Outcome Measures
Outcome Measure |
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Development of resistance to antiretroviral therapy during the 18 months of the study
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Appearance of specific CD4 proliferative responses against HIV during the 18 months of the study
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Appearance of specific cytotoxic responses against HIV during the 18 months of the study
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Number of patients under 5000 copies/mL after 6 months of stopping HAART
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Development of symptoms C during the 18 months of the study
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Deaths during the 18 months of the study
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Toxicity during the 18 months of the study
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: José Mª Gatell, MD, Hospital Clinic of Barcelona
- Study Chair: José Mª Miró, MD, Hospital Clinic of Barcelona
- Study Chair: José Mª Bayas, MD, Hospital Clinic of Barcelona
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2003
Study Completion
March 1, 2006
Study Registration Dates
First Submitted
May 22, 2006
First Submitted That Met QC Criteria
May 22, 2006
First Posted (Estimate)
May 24, 2006
Study Record Updates
Last Update Posted (Estimate)
May 24, 2006
Last Update Submitted That Met QC Criteria
May 22, 2006
Last Verified
May 1, 2006
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 02-0490; EARTH-06
- VAC-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.