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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:
ClinicalTrials.gov Identifier:
NCT00329251
First Posted: May 24, 2006
Last Update Posted: May 24, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hospital Clinic of Barcelona
  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
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

Resource links provided by NLM:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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