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The current available antiretroviral (ARV) agents make possible a successful treatment of virtually all HIV-infected patients, but some problems related to early mortality are still of concern, mainly in resources-limited settings. There are several published reports showing that such patients are at a significantly higher risk of death during the first months of treatment, in comparison with the observed outcomes in developed countries. One of the consistently detected risks for early mortality across these reports is the baseline low CD4 count, although it does not seem to be the only reason for such outcome. In Brazil and other developing countries, there is still a large proportion of AIDS patients who are diagnosed with AIDS, or only seek health care for HIV infection late in the course of disease. Dolutegravir (DTG), the first HIV-1 integrase inhibitor, is a potent and safe ARV drug. The available evidence suggest it promotes a faster decline in HIV-1 plasma viremia, and a higher increase in CD4 cells count, in comparison with those in Efavirenz (EFV) arm. The investigators propose to compare the impact of DTG versus EFV in the early mortality rates for severely ill (CD4+ cells count <50 cells/mm3) patients starting ARV therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dolutegravir | Experimental | Intervention: Patients will receive ART regimen based on investigational drug Dolutegravir 50 mg QD + TDF 300 mg QD+ 3TC 150 mg BID |
|
| Efavirenz | Active Comparator | Intervention: Patients who received ART regimen based efavirenz (EFV 600 mg QD +TDF 300 mg QD+ 3TC 300 mg QD) for one year, befor the use of DTG as SOC for first-line therapy (historic controls) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dolutegravir 50 mg | Drug | Use of Dolutegravir -based regimens: patients will receive a Dolutegravir -based ART regimen (RAL 400 mg BID + TDF 300 mg QD + 3TC 150 mg BID) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Early Mortality | Proportion of deaths in each group | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Viral Load | 24 months | |
| CD4 Count | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundação Bahiana de Infectologia/SEI | Salvador | Estado de Bahia | 40010-160 | Brazil | ||
| Universidade Federal do Rio de Janeiro |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dolutegravir | Intervention: Patients will receive ART regimen based on investigational drug Dolutegravir 50 mg QD + TDF 300 mg QD+ 3TC 150 mg BID Dolutegravir 50 mg: Use of Dolutegravir -based regimens: patients will receive a Dolutegravir -based ART regimen (RAL 400 mg BID + TDF 300 mg QD + 3TC 150 mg BID) |
| FG001 | Efavirenz | Intervention: Patients who received ART regimen based efavirenz (EFV 600 mg QD +TDF 300 mg QD+ 3TC 300 mg QD) for one year, befor the use of DTG as SOC for first-line therapy (historic controls) Efavirenz-based regimens: Efavirenz-based regimens: patients will receive an EFV-based regimen (EFV 600 mg QD + TDGF 300 mg QD + 3TC 300 mg QD) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Efavirenz | Intervention: Patients who received ART regimen based efavirenz (EFV 600 mg QD +TDF 300 mg QD+ 3TC 300 mg QD) for one year, befor the use of DTG as SOC for first-line therapy (historic controls) Efavirenz-based regimens: Efavirenz-based regimens: patients will receive an EFV-based regimen (EFV 600 mg QD + TDGF 300 mg QD + 3TC 300 mg QD) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Early Mortality | Proportion of deaths in each group | Posted | Count of Participants | Participants | 6 months |
|
|
Adverse events leading to interruption/change of ART in the 48 weeks period
Proportion of adverse events leading to ART interruption were recorded, by group
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dolutegravir | Patients treated with Dolutegravir | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| death | General disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CNS disturbances | Psychiatric disorders | Non-systematic Assessment | dizziness, sleep disturbance |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Carlos Brites | Federal University of Bahia | +5555992329552 | crbrites@hotmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 6, 2020 | Mar 10, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 20, 2018 | Feb 15, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C562325 | dolutegravir |
| C098320 | efavirenz |
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|
| Efavirenz-based regimens | Drug | Efavirenz-based regimens: patients will receive an EFV-based regimen (EFV 600 mg QD + TDGF 300 mg QD + 3TC 300 mg QD) |
|
|
| Rio de Janeiro |
| Rio de Janeiro |
| Brazil |
| Hospital de Clinicas de Porto Alegre | Porto Alegre | Rio Grande do Sul | Brazil |
| BG001 |
| Dolutegravir |
Intervention: Patients will receive ART regimen based on investigational drug Dolutegravir 50 mg QD + TDF 300 mg QD+ 3TC 150 mg BID Dolutegravir 50 mg: Use of Dolutegravir -based regimens: patients will receive a Dolutegravir -based ART regimen (RAL 400 mg BID + TDF 300 mg QD + 3TC 150 mg BID) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| CD4 (cell/mm3) | Mean | Standard Deviation | cells/mm3 |
|
| Viral load (copies/mL | Median | Inter-Quartile Range | log 10 copies/ml |
|
|
| Secondary | Viral Load | Not Posted | 24 months | Participants |
| Secondary | CD4 Count | Not Posted | 24 months | Participants |
| 92 |
| 9 |
| 92 |
| 0 |
| 92 |
| EG001 | Efavirenz | Patients treated with Efavirenz | 13 | 92 | 13 | 92 | 11 | 92 |
|
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