Clinical trial NCT01837277: Impact of a Dolutegravir-based Regimen on Early Mortality of AIDS Patients
Official title: Impact of a Dolutegravir-based Regimen on Early Mortality of Severely Immunocompromised AIDS Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Severely Immunocompromised HIV Patients
Lead sponsor: Fundação Bahiana de Infectologia
Sponsor class: OTHER
First posted: 2013-04-23
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Early Mortality
timeFrame: 6 months
Secondary outcomes:
measure: Viral Load
timeFrame: 24 months
measure: CD4 Count
timeFrame: 24 months
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Fundação Bahiana de Infectologia/SEI
state: Bahia
city: Rio de Janeiro
country: Brazil
facility: Universidade Federal do Rio de Janeiro
state: RJ
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: RS
Study officials:
References: