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

Hospital Clinic of Barcelona

Status and phase

Completed

Phase 4

Conditions

HIV

Treatments

Biological: Pneumococcal

Biological: Hepatitis B

Biological: Influenza

Biological: Tetanus-diphteria

Biological: Varicella

Biological: Hepatitis A

Biological: Measles-Mumps-Rubella

Study type

Interventional

Funder types

Other

Identifiers

NCT00329251

VAC-01

02-0490 EARTH-06;

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria