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

Sponsor

Fundação Bahiana de Infectologia (Other)

Overall Status

Completed

CT.gov ID

NCT01837277

Collaborator

(none)

186

Enrollment

Locations

Arms

45.5

Actual Duration (Months)

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Severely Immunocompromised HIV Patients	Drug: Dolutegravir 50 mg Drug: Efavirenz-based regimens	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

186 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 15, 2017

Actual Primary Completion Date :

Jul 31, 2021

Actual Study Completion Date :

Sep 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dolutegravir 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 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) Other Names: Tivicay
Active Comparator: 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)	Drug: 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) Other Names: Efavirenz

Arm

Intervention/Treatment

Experimental: Dolutegravir

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

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)

Other Names:

Tivicay

Active Comparator: 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)

Drug: 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)

Other Names:

Efavirenz

Outcome Measures

Primary Outcome Measures

early mortality [6 months]

Secondary Outcome Measures

Viral load [24 months]
CD4 count [24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fundação Bahiana de Infectologia/SEI	Salvador	Bahia	Brazil	40010-160
2	Universidade Federal do Rio de Janeiro	Rio de Janeiro	RJ	Brazil
3	Hospital de Clinicas de Porto Alegre	Porto Alegre	RS	Brazil

Sponsors and Collaborators

Fundação Bahiana de Infectologia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Carlos Brites, Senior Investigator, Fundação Bahiana de Infectologia

ClinicalTrials.gov Identifier:

NCT01837277

Other Study ID Numbers:

SevereHIV

First Posted:

Apr 23, 2013

Last Update Posted:

Mar 16, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Efavirenz

Dolutegravir

Study Results

No Results Posted as of Mar 16, 2022