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

Sponsor

Hospital Clinic of Barcelona (Other)

Overall Status

Completed

CT.gov ID

NCT00329251

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV	Biological: Hepatitis A Biological: Hepatitis B Biological: Influenza Biological: Pneumococcal Biological: Tetanus-diphteria Biological: Varicella Biological: Measles-Mumps-Rubella	Phase 4

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

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

Study Start Date :

Apr 1, 2003

Study Completion Date :

Mar 1, 2006

Outcome Measures

Primary Outcome Measures

Times viral load increases over 20.000 copies/mL. []

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Infectious Diseases, Hospital Clínic, C/Villarroel 170	Barcelona		Spain	08036

Sponsors and Collaborators

Hospital Clinic of Barcelona

Investigators

Study Chair: José Mª Gatell, MD, Hospital Clínic of Barcelona
Study Chair: José Mª Miró, MD, Hospital Clínic of Barcelona
Study Chair: José Mª Bayas, MD, Hospital Clínic of Barcelona

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00329251

Other Study ID Numbers:

02-0490; EARTH-06
VAC-01

First Posted:

May 24, 2006

Last Update Posted:

May 24, 2006

Last Verified:

May 1, 2006

Keywords provided by , ,

Study Results

No Results Posted as of May 24, 2006