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Phase IV, single-center, open study to assess the benefits of the start of immediate treatment without immunovirological data ("Same Day Treatment") compared to conventional treatment with BIC / FTC / TAF in naive patients with type 1 HIV (human immunodeficiency virus) infection
150 patients (75 in each treatment arm) with a confirmed diagnosis of HIV-1 infection and without prior antiretroviral treatment will be included.
Expected study period 48 weeks of treatment Main objective of effectiveness Determine the time from the first determination of CD4 and HIV-1 viral load to achieve HIV viral load <50 cop / ml.
Secondary objectives of efficacy
The treatment guidelines will be as follows:
It is a single-center, open and non-randomized study. 150 adult patients with confirmed diagnosis of HIV-1 and without prior antiretroviral treatment may participate in the study.
Patients will be divided into two groups, one in immediate treatment (arm 1 or SDT) and another in conventional treatment (arm 2), both strategies being considered part of the usual clinical practice that leads to a low intervention study.
Patients will voluntarily grant informed consent before performing any study procedure and will be assigned a patient code for the entire study.
The study will include a total of 5 visits and periodic clinical exams will be performed on visits of weeks 0, 4, 12, 24 and 48.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SDT | Experimental | -75 patients of immediate treatment, will be those patients without immuno-virological data that accept to start the treatment the same day of the first consultation with the hospital specialist (arm 1 or SDT). |
|
| Conventional | Active Comparator | - 75 patients of conventional treatment, will be those who in their first consultation with the hospital specialist already have previous immuno-virological data or reject the start of immediate treatment (arm 2 or conventional). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIC/FTC/TAF: Bictegravir/emtricitabina/tenofovir alafenamida fumarato | Drug | This is a study to assess the impact of immediate ART (FAST ART or SDT) against conventional treatment (CT) on the time to reach an undetectable HIV-1 viral load. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of immediate treatment. | The time in weeks from the first determination of CD4 and HIV-1 viral load until achieving HIV viral load <50 cop/ml, in number. | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Efficacy Endpoints |
|
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Inclusion Criteria:
- Men and women > 18 years old
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital FUNDACIÓN JIMÉNEZ DÍAZ | Madrid | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16791020 | Result | Marks G, Crepaz N, Janssen RS. Estimating sexual transmission of HIV from persons aware and unaware that they are infected with the virus in the USA. AIDS. 2006 Jun 26;20(10):1447-50. doi: 10.1097/01.aids.0000233579.79714.8d. | |
| 28867497 | Result | Gallant J, Lazzarin A, Mills A, Orkin C, Podzamczer D, Tebas P, Girard PM, Brar I, Daar ES, Wohl D, Rockstroh J, Wei X, Custodio J, White K, Martin H, Cheng A, Quirk E. Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial. Lancet. 2017 Nov 4;390(10107):2063-2072. doi: 10.1016/S0140-6736(17)32299-7. Epub 2017 Aug 31. |
| Label | URL |
|---|---|
| UNAIDS is leading the global effort to end AIDS as a public health threat by 2030 as part of the Sustainable Development Goals. | View source |
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| 48 weeks |
| GUIDELINES FOR MANAGING ADVANCED HIV DISEASE AND RAPID INITIATION OF ANTIRETROVIRAL THERAPY | View source |