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

NCT00329251 | Completed Phase 4

• 2 other identifiers: 02-0490; EARTH-06VAC-01
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

HIV; Viral load; Vaccines; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Times viral load increases over 20.000 copies/mL.

Secondary Outcomes (7)

• 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

Interventions

Hepatitis A BIOLOGICAL

Hepatitis B BIOLOGICAL

Influenza BIOLOGICAL

Pneumococcal BIOLOGICAL

Tetanus-diphteria BIOLOGICAL

Varicella BIOLOGICAL

Measles-Mumps-Rubella BIOLOGICAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years
• Asymptomatic HIV infection
• CD4 nadir \>300/mm3
• Viral load previous to treatment \>5000 copies/mL
• Informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Department of Infectious Diseases, Hospital Clínic, C/Villarroel 170

Barcelona, Barcelona, 08036, Spain

Location

Related Publications (3)

• Yek C, Gianella S, Plana M, Castro P, Scheffler K, Garcia F, Massanella M, Smith DM. Standard vaccines increase HIV-1 transcription during antiretroviral therapy. AIDS. 2016 Sep 24;30(15):2289-98. doi: 10.1097/QAD.0000000000001201.

  PMID: 27427877 DERIVED

• Castro P, Torres B, Lopez A, Gonzalez R, Vilella A, Nicolas JM, Gallart T, Pumarola T, Sanchez M, Leal M, Vallejo A, Bayas JM, Gatell JM, Plana M, Garcia F. Effects of different antigenic stimuli on thymic function and interleukin-7/CD127 system in patients with chronic HIV infection. J Acquir Immune Defic Syndr. 2014 Aug 15;66(5):466-72. doi: 10.1097/QAI.0000000000000207.

  PMID: 24820104 DERIVED

• Castro P, Plana M, Gonzalez R, Lopez A, Vilella A, Nicolas JM, Gallart T, Pumarola T, Bayas JM, Gatell JM, Garcia F. Influence of episodes of intermittent viremia ("blips") on immune responses and viral load rebound in successfully treated HIV-infected patients. AIDS Res Hum Retroviruses. 2013 Jan;29(1):68-76. doi: 10.1089/AID.2012.0145. Epub 2012 Dec 16.

  PMID: 23121249 DERIVED

MeSH Terms

Interventions

Hepatitis A Vaccines; Hepatitis B Vaccines; Influenza Vaccines

Intervention Hierarchy (Ancestors)

Viral Hepatitis Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• 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 CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 22, 2006
• First Posted: May 24, 2006
• Study Start: April 1, 2003
• Study Completion: March 1, 2006
• Last Updated: May 24, 2006

Record last verified: 2006-05

Locations

ES (1)