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

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.

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.

Inclusion Criteria:

• Age >18 years
• Asymptomatic HIV infection
• CD4>500/mm3 >6 months prior to inclusion
• CD4 nadir >300/mm3
• Being under HAART > 1 year prior to inclusion
• Viral load<200 copies/mL > 6 months prior to inclusion
• Viral load previous to treatment >5000 copies/mL
• Informed consent

Exclusion Criteria:

• Pregnant women
• Basal creatinine >2.5 mg/dL
• Allergy to either a vaccine or a ingredient of it
• Chronic hepatitis B
• GOT/GPT > 250 IU/L