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

Phase 4

Completed

• Conditions: HIV

• Registration Number: NCT00329251
• Lead Sponsor: Hospital Clinic of Barcelona

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.

Study Timeline

• Study Start: 2003-04
• Study Completion: 2006-03
• Status Verified: 2006-05
• Study First Submitted: 2006-05-22
• Study First Submitted QC: 2006-05-22
• Last Update Submitted: 2006-05-22
• Study First Posted: 2006-05-24
• Last Update Posted: 2006-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Times viral load increases over 20.000 copies/mL.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Infectious Diseases, Hospital Clínic, C/Villarroel 170; 🇪🇸 Barcelona, Spain