Status:
COMPLETED
Impact of a Dolutegravir-based Regimen on Early Mortality of AIDS Patients
Lead Sponsor:
Fundação Bahiana de Infectologia
Conditions:
Severely Immunocompromised HIV Patients
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- Undetectable plasma viral load at screening
- CD4 cells count\>50 cells/mm3
- Asymptomatic individuals
Key Trial Info
Start Date :
December 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2021
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT01837277
Start Date
December 15 2017
End Date
September 30 2021
Last Update
December 14 2023
Active Locations (3)
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1
Fundação Bahiana de Infectologia/SEI
Salvador, Estado de Bahia, Brazil, 40010-160
2
Universidade Federal do Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, Brazil
3
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil