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| Name | Class |
|---|---|
| Fundacion Clinic per a la Recerca Biomédica | OTHER |
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Pilot study to evaluate the impact of extremely early ART in the dynamics of viral reservoir, immune activation and inflammation in patients with HIV-1 infection of less than 20 days (Fiebig stages I-II) compared to patients with infection of 20-100 days (Fiebig stages III-V), to induce HIV functional cure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antiretroviral treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antiretroviral Therapy (Experimental) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Functional cure (Proportion of patients with undetectable viral reservoir) | Proportion of patients in both groups with undetectable viral reservoir in peripheral and rectal tissue CD4+ T cells. A viral load will be performed at 1, 3 and 12 months after ART initiation and in rectal tissue at one year post-ART initiation. | 12 months of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with undetectable plasmatic HIV viral load | In those patients with undetectable viral reservoir stopping antiretroviral treatment at 12 months | 1, 3 and 12 months post-stop antiretroviral treatment will be evaluated. |
| Level of reduction of viral reservoir among patients treated in phase I-II Fiebig and patients treated in Fiebig stage III-V |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clínic i Provincial de Barcelona | Recruiting | Barcelona | Barcelona | 08036 | 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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| 1, 3, 12 months will be measured in patients on antiretroviral treatment and at 1, 3, 12 months post-stop |
| Level of reduction of bacterial translocation among patients treated in phase I-II Fiebig and patients treated in Fiebig stage III-V | 1, 3, 12 months will be measured in patients on antiretroviral treatment and at 1, 3, 12 months post-stop |
| Level of reduction of immune activation among patients treated in phase I-II Fiebig and patients treated in Fiebig stage III-V | 1, 3, 12 months will be measured in patients on antiretroviral treatment and at 1, 3, 12 months post-stop |
| Level of reduction of inflammation among patients treated in phase I-II Fiebig and patients treated in Fiebig stage III-V | 1, 3, 12 months will be measured in patients on antiretroviral treatment and at 1, 3, 12 months post-stop |
| 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 |