Study of the Influence of Vaccination in HIV Viral Load and Immunologic Responses Against HIV
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.
Biological: Hepatitis A
Biological: Hepatitis B
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|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|
- 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
|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.
|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|