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

Study Overview
=================
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.

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

Conditions
-----------------
HIV

Intervention / Treatment
-----------------
* Biological: Hepatitis A
* Biological: Hepatitis B
* Biological: Influenza
* Biological: Pneumococcal
* Biological: Tetanus-diphteria
* Biological: Varicella
* Biological: Measles-Mumps-Rubella


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Hepatitis A|nan|
|Biological: Hepatitis B|nan|
|Biological: Influenza|nan|
|Biological: Pneumococcal|nan|
|Biological: Tetanus-diphteria|nan|
|Biological: Varicella|nan|
|Biological: Measles-Mumps-Rubella|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Times viral load increases over 20.000 copies/mL. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, Viral load, Vaccines, Immunotherapy