A Phase 2/3 interventional study of Dolutegravir 50 mg and Efavirenz-based regimens in Severely Immunocompromised HIV Patients, sponsored by Fundação Bahiana de Infectologia. Completed at 3 sites in Brazil. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-12-14.
Sponsored by Fundação Bahiana de Infectologia · Phase 2/3, Interventional, and Treatment
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.
Fundação Bahiana de Infectologia is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intervention: Patients will receive ART regimen based on investigational drug Dolutegravir 50 mg QD + TDF 300 mg QD+ 3TC 150 mg BID
Drug: Dolutegravir 50 mg
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)
Drug: Efavirenz-based regimens
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)
Also known as: Tivicay
Efavirenz-based regimens: patients will receive an EFV-based regimen (EFV 600 mg QD + TDGF 300 mg QD + 3TC 300 mg QD)
Also known as: Efavirenz
Early Mortality
Proportion of deaths in each group
Time frame: 6 months
Viral Load
Time frame: 24 months
CD4 Count
Time frame: 24 months
| Milestone | Dolutegravir | Efavirenz |
|---|---|---|
| Started | 92 | 92 |
| Completed | 70 | 48 |
| Not completed | 22 | 44 |
Proportion of deaths in each group
| Participants | Dolutegravir | Efavirenz |
|---|---|---|
| Early Mortality | 9 | 13 |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Collected over Adverse events leading to interruption/change of ART in the 48 weeks period. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dolutegravir | 9/92 (9.8%) | 9/92 (9.8%) | 0/92 (0%) |
| Efavirenz | 13/92 (14.1%) | 13/92 (14.1%) | 11/92 (12%) |
| Event | Dolutegravir | Efavirenz |
|---|---|---|
| deathGeneral disorders | 9/92 | 13/92 |
| Event | Dolutegravir | Efavirenz |
|---|---|---|
| CNS disturbancesPsychiatric disorders | 0/92 | 11/92 |
| Age, Continuous(years) | Efavirenz | Dolutegravir | Total |
|---|---|---|---|
| Mean | 37.3 ± 8.9 | 39.3 ± 11.5 | 38.3 ± 10.3 |
| Sex: Female, Male(Participants) | Efavirenz | Dolutegravir | Total |
|---|---|---|---|
| Female | 33 | 63 | 96 |
| Male | 59 | 29 | 88 |
| Race/Ethnicity, Customized(Participants) | Efavirenz | Dolutegravir | Total |
|---|---|---|---|
| White | 20 | 21 | 41 |
| Black | 15 | 5 | 20 |
| Asian | 1 | 0 | 1 |
| More than one race | 28 | 28 | 56 |
| Not reported | 28 | 48 | 76 |
| Region of Enrollment(Participants) | Efavirenz | Dolutegravir | Total |
|---|---|---|---|
| Brazil | 92 | 92 | 184 |
| CD4 (cell/mm3)(cells/mm3) | Efavirenz | Dolutegravir | Total |
|---|---|---|---|
| Mean | 23 ± 14 | 23 ± 14 | 23 ± 14 |
| Viral load (copies/mL(log 10 copies/ml) | Efavirenz | Dolutegravir | Total |
|---|---|---|---|
| Median | 5.6 (5.1 to 5.9) | 5.5 (5.0 to 5.9) | 5.5 (5.0 to 5.9) |
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Fundação Bahiana de Infectologia