Impact of a Dolutegravir-based Regimen on Early Mortality of AIDS Patients

Severely Immunocompromised HIV Patients Clinical Trial

— IDEA  

Official title:

Impact of a Dolutegravir-based Regimen on Early Mortality of Severely Immunocompromised AIDS Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01837277
• Other study ID #: SevereHIV
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: December 15, 2017
• Est. completion date: September 30, 2021

Study information

• Verified date: March 2023
• Source: Fundação Bahiana de Infectologia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: September 30, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients with confirmed HIV-1 infection (positive Western blot or plasma HIV-1 RNA >1,000 copies/ml)
• No previous use of any ARV drug (drug-naïve patients)
• Presence of clinical symptoms according to Rio de Janeiro / Caracas´ AIDS definition (Asthenia, Cachexia/Wasting, Cough, Dermatitis, persistent, Diarrhea, Fever, Lymphadenopathy, Candidiasis, oral, or hairy leukoplasia, Central nervous system dysfunction, Herpes zoster in individual younger than 60 years of age)), and/or any active AIDS-defining condition
• Baseline CD4+ cells count equal or lower than 50 cells/mm3
• Age equal or higher than 18 years
• HIV-1 plasma viral load = 1,000 copies of HIV-1 RNA/ml

Exclusion Criteria:

• Undetectable plasma viral load at screening
• CD4 cells count>50 cells/mm3
• Asymptomatic individuals

Related Conditions & MeSH terms

• Severely Immunocompromised HIV Patients

Intervention

Drug:
• 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)
• 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)

Locations

Country	Name	City	State
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	RS
Brazil	Universidade Federal do Rio de Janeiro	Rio de Janeiro	RJ
Brazil	Fundação Bahiana de Infectologia/SEI	Salvador	Bahia

Sponsors (1)

Lead Sponsor	Collaborator
Fundação Bahiana de Infectologia

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early Mortality	Proportion of deaths in each group	6 months
Secondary	Viral Load		24 months
Secondary	CD4 Count		24 months