Study of the Influence of Vaccination in HIV Viral Load and Immunologic Responses Against HIV
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|ClinicalTrials.gov Identifier: NCT00329251|
Recruitment Status : Completed
First Posted : May 24, 2006
Last Update Posted : May 24, 2006
|Condition or disease||Intervention/treatment||Phase|
|HIV||Biological: Hepatitis A Biological: Hepatitis B Biological: Influenza Biological: Pneumococcal Biological: Tetanus-diphteria Biological: Varicella Biological: Measles-Mumps-Rubella||Phase 4|
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 (Clinical Trial)|
|Estimated Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||April 2003|
|Estimated Study Completion Date :||March 2006|
- Times viral load increases over 20.000 copies/mL.
- Development of resistance to antiretroviral therapy during the 18 months of the study
- Appearance of specific CD4 proliferative responses against HIV during the 18 months of the study
- Appearance of specific cytotoxic responses against HIV during the 18 months of the study
- Number of patients under 5000 copies/mL after 6 months of stopping HAART
- Development of symptoms C during the 18 months of the study
- Deaths during the 18 months of the study
- Toxicity during the 18 months of the study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00329251
|Department of Infectious Diseases, Hospital Clínic, C/Villarroel 170|
|Barcelona, Spain, 08036|
|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|