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

This study has been completed.
Sponsor:
Information provided by:
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00329251
First received: May 22, 2006
Last updated: NA
Last verified: May 2006
History: No changes posted
  Purpose

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 Intervention Phase
HIV
 Biological: Hepatitis A
Biological: Hepatitis B
Biological: Influenza
Biological: Pneumococcal
Biological: Tetanus-diphteria
Biological: Varicella
Biological: Measles-Mumps-Rubella
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital Clinic of Barcelona:

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

Estimated Enrollment: 26
Study Start Date: April 2003
Estimated Study Completion Date: March 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00329251

Locations
Spain
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00329251     History of Changes
Other Study ID Numbers: 02-0490; EARTH-06, VAC-01
Study First Received: May 22, 2006
Last Updated: May 22, 2006
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Hospital Clinic of Barcelona:
HIV
Viral load
Vaccines
Immunotherapy

ClinicalTrials.gov processed this record on May 16, 2013