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| ID | Type | Description | Link |
|---|---|---|---|
| VAC-01 |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hepatitis A | Biological | |||
| Hepatitis B | Biological | |||
| Influenza | Biological | |||
| Pneumococcal | Biological | |||
| Tetanus-diphteria | Biological | |||
| Varicella | Biological | |||
| Measles-Mumps-Rubella | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| Times viral load increases over 20.000 copies/mL. |
| Measure | Description | Time Frame |
|---|---|---|
| Development of resistance to antiretroviral therapy during the 18 months of the study | ||
| Appearance of specific CD4 proliferative responses against HIV during the 18 months of the study | ||
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| José Mª Gatell, MD | Hospital ClÃnic of Barcelona | Study Chair |
| José Mª Miró, MD | Hospital ClÃnic of Barcelona | Study Chair |
| José Mª Bayas, MD | Hospital ClÃnic of Barcelona | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Infectious Diseases, Hospital ClÃnic, C/Villarroel 170 | Barcelona | Barcelona | 08036 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27427877 | Derived | Yek C, Gianella S, Plana M, Castro P, Scheffler K, Garcia F, Massanella M, Smith DM. Standard vaccines increase HIV-1 transcription during antiretroviral therapy. AIDS. 2016 Sep 24;30(15):2289-98. doi: 10.1097/QAD.0000000000001201. | |
| 24820104 | Derived | Castro P, Torres B, Lopez A, Gonzalez R, Vilella A, Nicolas JM, Gallart T, Pumarola T, Sanchez M, Leal M, Vallejo A, Bayas JM, Gatell JM, Plana M, Garcia F. Effects of different antigenic stimuli on thymic function and interleukin-7/CD127 system in patients with chronic HIV infection. J Acquir Immune Defic Syndr. 2014 Aug 15;66(5):466-72. doi: 10.1097/QAI.0000000000000207. |
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| ID | Term |
|---|---|
| D022362 | Hepatitis A Vaccines |
| D017325 | Hepatitis B Vaccines |
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| Appearance of specific cytotoxic responses against HIV during the 18 months of the study |
| Number of patients under 5000 copies/mL after 6 months of stopping HAART |
| Development of symptoms C during the 18 months of the study |
| Deaths during the 18 months of the study |
| Toxicity during the 18 months of the study |
| 23121249 | Derived | Castro P, Plana M, Gonzalez R, Lopez A, Vilella A, Nicolas JM, Gallart T, Pumarola T, Bayas JM, Gatell JM, Garcia F. Influence of episodes of intermittent viremia ("blips") on immune responses and viral load rebound in successfully treated HIV-infected patients. AIDS Res Hum Retroviruses. 2013 Jan;29(1):68-76. doi: 10.1089/AID.2012.0145. Epub 2012 Dec 16. |
| D045424 |
| Complex Mixtures |