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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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Antiretroviral treatment for HIV has allowed patients to have undetectable viral load indefinitely. Despite that, HIV infection has become a chronic inflammatory disease, with increased mortality. This pro-inflammatory state is in part explained by the dysbiosis of intestinal bacterial populations. However, little is known on the impact of the antiretroviral treatment on this population and very few studies have evaluated these alterations.
The aim of this study is to study microbiome on healthy patients and HIV-infected patients exposed to antiretroviral treatment with integrase strand transfer inhibitors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MSM HIV-uninfected and ART naïve | Men who have sex with men without HIV infection, not receiving ART | ||
| MSM HIV-infected starting ART | Men who have sex with men with HIV infection, starting ART |
| |
| MSM HIV-infected on ART with >500 CD4 Tcells | Men who have sex with men with HIV infection, on ART and with >500 CD4 T cells/uL |
| |
| MSM HIV-infected on ART with <350 CD4 Tcells | Men who have sex with men with HIV infection, on ART and with <350 CD4 T cells/uL |
| |
| MSM HIV negative patients starting PEP with INST | Men who have sex with men without HIV infection, starting post-exposure prophylaxis with raltegravir |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Integrase strand transfer inhibitors | Drug | Integrase strand transfer inhibitors as post-exposure prophylaxis or as antiretroviral treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Alpha diversity changes of fecal microbiota composition | Alpha diversity changes of fecal microbiota composition between study groups | Baseline and 1 month, 3 months, 12 months |
| Beta diversity changes of fecal microbiota composition | Beta diversity changes of fecal microbiota composition between study groups | Baseline and 1 month, 3 months, 12 months |
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Inclusion criteria:
Willing to sign consent form
Men with an age >18 years
Engagement in insertive or receptive anal intercourse with another men
*Exclusion criteria:
Previous history of ART exposure
Use of antibiotics in the past 3 months
Previous history of inflammatory bowel disease, autoimmune disease or cirrhosis.
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We will compare 20 MSM HIV negative patients starting PEP with INSTI with:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Ramón y Cajal and Hospital Clínico San Carlos | Madrid | 28034 | Spain |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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Feces
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |