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Sponsored by: |
Hospital Clinic of Barcelona |
Information provided by: | Hospital Clinic of Barcelona |
ClinicalTrials.gov Identifier: | NCT00329251 |
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.
Condition | Intervention | Phase |
HIV |
Biological: Hepatitis A Biological: Hepatitis B Biological: Influenza Biological: Pneumococcal Biological: Tetanus-diphteria Biological: Varicella Biological: Measles-Mumps-Rubella |
Phase IV |
MedlinePlus related topics: | AIDS Hepatitis Hepatitis A Hepatitis B |
ChemIDplus related topics: | Hepatitis B Vaccines |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 26 |
Study Start Date: | April 2003 |
Estimated Study Completion Date: | March 2006 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Spain | |||||
Department of Infectious Diseases, Hospital Clínic, C/Villarroel 170 | |||||
Barcelona, Spain, 08036 |
Hospital Clinic of Barcelona |
Study Chair: | José Mª Gatell, MD | Hospital Clínic of Barcelona |
Study Chair: | José Mª Miró, MD | Hospital Clínic of Barcelona |
Study Chair: | José Mª Bayas, MD | Hospital Clínic of Barcelona |
Study ID Numbers: | 02-0490; EARTH-06, VAC-01 |
First Received: | May 22, 2006 |
Last Updated: | May 22, 2006 |
ClinicalTrials.gov Identifier: | NCT00329251 |
Health Authority: | Spain: Spanish Agency of Medicines |
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