Clinical Trials

MainTitle

Induction and Expansion of T Cell Repertoire Using Growth Hormone and Vaccination in HIV-1 Infected Patients

Purpose

Purpose

Concomitant administration of recombinant human growth hormone (rhGH) may boost the expansion of immune reconstitution and broaden specific T cell responses not achievable by vaccination alone. The main objective of that study is to test the validity of this hypothesis with vaccines which are routinely administered to HIV-1 patients(tetanus toxoid and hepatitis A virus vaccines) in order to, if proven of value, use this strategy of HIV vaccination in the near future. This is a pilot, randomized, clinical open label study aimed to investigate thymic functionality and the HIV-specific responses after administration of rhGH in HIV-1 infected patients in highly active antiretroviral therapy (HAART) regimen.

Further study details as provided by Germans Trias i Pujol Hospital:

Primary Outcome Measures

• Proportion of patients HIV+ that recover the immunospecific responses against tetanus toxoid and Hepatitis A at 24 weeks of rhGH administration (time of treatment interruption). [ Time Frame: from 24 weeks post rhGH administration ]

Secondary Outcome Measures:

• The rhGH activates the thymic function. [ Time Frame: from one year post rhGH administration ]
• This effect is lasting once the rhGH administration is interrupted. [ Time Frame: from at least one year since the last rhGH administration ]

Detailed Description:

The purpose of a therapeutic vaccine is to control, induce and expand humoral and cellular immune responses capable to control HIV infection. The administration of a conventional vaccine results in the expansion of peripheral clones. Concomitant administration of rhGH may boost this expansion and reconstitute specific T cell responses not achievable by vaccination alone. In this study we want to investigate whether the administration of rhGH expand T cell repertoire and whether there is an increase in the specific cellular responses to HIV-1 and recall antigens and, lately, whether this responses can be further amplified after immunization with tetanus toxoid and hepatitis A vaccines. This Hypothesis will be evaluated by the measurement of thymic volume, the expansion of naïve, memory and effector cell subsets, analysis of thymic emigrants (TRECs) before, during and after rhGH administration and vaccination. Moreover, T cell receptor rearrangement, specific antibodies and cellular responses to antigenic peptides will be determined.

Eligibility

Eligibility

Criteria

Inclusion Criteria:

1. HIV-1 asymptomatic patients in HAART regimen (> 6 months)
2. Viral load < 50 copies/ml
3. Number CD4 cells > 250 cells/mm3
4. Non responders to vaccination (tetanus toxoid and/or Hepatitis A virus)
5. Well-disposition to rhGh daily administration (6 months of treatment)

Exclusion Criteria:

1. AIDS outbreak
2. Allergy or hyperreactivity to rhGH or vaccines
3. Diabetes Mellitus
4. Renal, hepatic, pancreatic disorders
5. Chronic diseases
6. Dementia
7. Pregnancy

contacts and locations

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00287677

Locations Show More

Sponsors and Collaborators

Germans Trias i Pujol Hospital
Hospital Clinic of Barcelona
Hospital General Universitario Gregorio Marañon
Carlos III Health Institute

Investigators

More Information

More Information

Keywords provided by Germans Trias i Pujol Hospital:

Growth Hormone
HIV-1
Vaccination
Thymopoiesis
HIV-specific responses
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Hormones

ClinicalTrials.gov processed this data on May 29, 2020
This information is provided by ClinicalTrials.gov.