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

HIV Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00329251
• Other study ID #: 02-0490; EARTH-06
• Secondary ID: VAC-01
• Status: Completed
• Phase: Phase 4
• First received: May 22, 2006
• Last updated: May 22, 2006
• Start date: April 2003
• Est. completion date: March 2006

Study information

• Verified date: May 2006
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV

Intervention

Biological:
• Hepatitis A

• Hepatitis B

• Influenza

• Pneumococcal

• Tetanus-diphteria

• Varicella

• Measles-Mumps-Rubella

Locations

Country	Name	City	State
Spain	Department of Infectious Diseases, Hospital Clínic, C/Villarroel 170	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Times viral load increases over 20.000 copies/mL.
Secondary	Development of resistance to antiretroviral therapy during the 18 months of the study
Secondary	Appearance of specific CD4 proliferative responses against HIV during the 18 months of the study
Secondary	Appearance of specific cytotoxic responses against HIV during the 18 months of the study
Secondary	Number of patients under 5000 copies/mL after 6 months of stopping HAART
Secondary	Development of symptoms C during the 18 months of the study
Secondary	Deaths during the 18 months of the study
Secondary	Toxicity during the 18 months of the study