HIV
Conditions
Keywords
HIV, Viral load, Vaccines, Immunotherapy
Brief 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.
Interventions
BIOLOGICALPneumococcal
BIOLOGICALTetanus-diphteria
BIOLOGICALVaricella
BIOLOGICALMeasles-Mumps-Rubella
BIOLOGICALHepatitis A
BIOLOGICALHepatitis B
BIOLOGICALInfluenza
Sponsors
Hospital Clinic of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Times viral load increases over 20.000 copies/mL. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 resistance to antiretroviral therapy during the 18 months of the study | — |
| Deaths during the 18 months of the study | — |
| Toxicity during the 18 months of the study | — |
| Development of symptoms C during the 18 months of the study | — |
Countries
Spain
Outcome results
None listed