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

Fundação Bahiana de Infectologia

Status and phase: Completed; Phase 3; Phase 2

Conditions: Severely Immunocompromised HIV Patients

Treatments: Drug: Efavirenz-based regimens; Drug: Dolutegravir 50 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT01837277

SevereHIV

Details and patient eligibility

About

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.

Enrollment: 186 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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186 participants in 2 patient groups

Dolutegravir

Experimental group

Description:

Intervention: Patients will receive ART regimen based on investigational drug Dolutegravir 50 mg QD + TDF 300 mg QD+ 3TC 150 mg BID

Treatment:

Drug: Dolutegravir 50 mg

Efavirenz

Active Comparator group

Description:

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)

Treatment:

Drug: Efavirenz-based regimens