drugset / Trial / NCT00287677
Induction and Expansion of T Cell Repertoire Using Growth Hormone and Vaccination in HIV-1 Infected Patients
Phase 4
Completed
33 enrolled
Germans Trias i Pujol Hospital
Carlos III Health Institute · collabHospital Clinic of Barcelona · collabHospital General Universitario Gregorio Marañon · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2006-01
- Primary completion
- 2009-07
- Completion
- 2009-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hepatitis A+B | Vaccine | — | — |
| Subject | Somatropin | Protein / enzyme biologic | 30 ug/kg | — |
| Subject | tetanus toxoid | Vaccine | — | — |