NCT00329251

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 26 (planned)
• Sponsor: Hospital Clinic of Barcelona · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

• HIV

Interventions

Type	Name	Description
BIOLOGICAL	Hepatitis A
BIOLOGICAL	Hepatitis B
BIOLOGICAL	Influenza
BIOLOGICAL	Pneumococcal
BIOLOGICAL	Tetanus-diphteria
BIOLOGICAL	Varicella
BIOLOGICAL	Measles-Mumps-Rubella

Timeline

• Start date: 2003-04-01
• Completion: 2006-03-01
• First posted: 2006-05-24
• Last updated: 2006-05-24

Locations

1 site across 1 country: Spain