Induction and Expansion of T Cell Repertoire Using Growth Hormone and Vaccination in HIV-1 Infected Patients
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ClinicalTrials.gov Identifier: NCT00287677 |
Recruitment Status :
Completed
First Posted : February 7, 2006
Last Update Posted : November 4, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Biological: recombinant human Growth Hormone Biological: Vaccination Drug: HAART | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 33 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Double Strategy to Induce and Expand the T Cell Repertoire by the Administration of Growth Hormone and Vaccination in HIV-1 Infected Patients |
Study Start Date : | January 2006 |
Actual Primary Completion Date : | July 2009 |
Actual Study Completion Date : | July 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: A
growth hormone + vaccination + HAART
|
Biological: recombinant human Growth Hormone
Growth Hormone during 6 months (30UG/KG/DAY) Biological: Vaccination Vaccination (Hepatitis A+B + tetanus toxoid) at week 16 Drug: HAART HAART all over the trial |
Experimental: B
growth hormone + HAART
|
Biological: recombinant human Growth Hormone
Growth Hormone during 6 months (30UG/KG/DAY) Drug: HAART HAART all over the trial |
Experimental: C
vaccination + HAART
|
Biological: Vaccination
Vaccination (Hepatitis A+B + tetanus toxoid) at week 16 Drug: HAART HAART all over the trial |
Active Comparator: D
control healthy HIV negative + vaccination
|
Biological: Vaccination
Vaccination (Hepatitis A+B + tetanus toxoid) at week 16 |
- 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 ]
- 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 ]

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Ages Eligible for Study: | 25 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- HIV-1 asymptomatic patients in HAART regimen (> 6 months)
- Viral load < 50 copies/ml
- Number CD4 cells > 250 cells/mm3
- Non responders to vaccination (tetanus toxoid and/or Hepatitis A virus)
- Well-disposition to rhGh daily administration (6 months of treatment)
Exclusion Criteria:
- AIDS outbreak
- Allergy or hyperreactivity to rhGH or vaccines
- Diabetes Mellitus
- Renal, hepatic, pancreatic disorders
- Chronic diseases
- Dementia
- Pregnancy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00287677
Spain | |
Germans Trias i Pujol Hospital | |
Badalona, Barcelona, Spain, 08916 | |
Hospital Clinic de Barcelona | |
Barcelona, Spain, 08036 |
Study Director: | Bonaventura Clotet, PhD | IrsiCaixa Foundation-Germans Trias i Pujol Hospital | |
Principal Investigator: | Lidia Ruiz, PhD | Irsicaixa Foundation-Germans Trias i Pujol Hospital | |
Study Director: | Jose Mª Gatell, PhD | Hospital Clinic of Barcelona | |
Study Director: | Margarita Bofill, PhD | Irsicaixa Foundation- Germans Trias i Pujol Hospital |
Responsible Party: | Germans Trias i Pujol Hospital |
ClinicalTrials.gov Identifier: | NCT00287677 |
Other Study ID Numbers: |
VIHCREC01 |
First Posted: | February 7, 2006 Key Record Dates |
Last Update Posted: | November 4, 2009 |
Last Verified: | November 2009 |
Growth Hormone HIV-1 Vaccination |
Thymopoiesis HIV-specific responses Treatment Experienced |
HIV Infections Blood-Borne Infections Communicable Diseases Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |
RNA Virus Infections Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |