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OpenTrials
Completed

NCT Number: NCT00329251

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

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.

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Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Barcelona, 08036, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hepatitis A

Biological

Hepatitis B

Biological

Influenza

Biological

Pneumococcal

Biological

Tetanus-diphteria

Biological

Varicella

Biological

Measles-Mumps-Rubella

Biological

Primary outcomes

  1. Times viral load increases over 20.000 copies/mL.

Secondary outcomes

  1. Development of resistance to antiretroviral therapy during the 18 months of the study

  2. Appearance of specific CD4 proliferative responses against HIV during the 18 months of the study

  3. Appearance of specific cytotoxic responses against HIV during the 18 months of the study

  4. Number of patients under 5000 copies/mL after 6 months of stopping HAART

  5. Development of symptoms C during the 18 months of the study

  6. Deaths during the 18 months of the study

  7. Toxicity during the 18 months of the study

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Official study 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

Important dates

Study start
2003
Study completion
2006
First posted
May 24, 2006
Registry last updated
May 24, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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