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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2009-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

growth hormone + vaccination + HAART

Group Type EXPERIMENTAL

recombinant human Growth Hormone

Intervention Type BIOLOGICAL

Growth Hormone during 6 months (30UG/KG/DAY)

Vaccination

Intervention Type BIOLOGICAL

Vaccination (Hepatitis A+B + tetanus toxoid) at week 16

HAART

Intervention Type DRUG

HAART all over the trial

B

growth hormone + HAART

Group Type EXPERIMENTAL

recombinant human Growth Hormone

Intervention Type BIOLOGICAL

Growth Hormone during 6 months (30UG/KG/DAY)

HAART

Intervention Type DRUG

HAART all over the trial

C

vaccination + HAART

Group Type EXPERIMENTAL

Vaccination

Intervention Type BIOLOGICAL

Vaccination (Hepatitis A+B + tetanus toxoid) at week 16

HAART

Intervention Type DRUG

HAART all over the trial

D

control healthy HIV negative + vaccination

Group Type ACTIVE_COMPARATOR

Vaccination

Intervention Type BIOLOGICAL

Vaccination (Hepatitis A+B + tetanus toxoid) at week 16

Interventions

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recombinant human Growth Hormone

Growth Hormone during 6 months (30UG/KG/DAY)

Intervention Type BIOLOGICAL

Vaccination

Vaccination (Hepatitis A+B + tetanus toxoid) at week 16

Intervention Type BIOLOGICAL

HAART

HAART all over the trial

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes