Last updated 9 days ago

Dolutegravir/Lamivudine Dual Therapy for ART-naïve People With HIV and TB Receiving Rifampin-based TB Treatment

150 patients around the world
Available in Brazil
Tuberculosis (TB) is the most common cause of death in people with HIV worldwide. Among patients with HIV, the incidence of TB per year is about 5-10%. The two diseases are now always treated concurrently in co-infected individuals, as there is a survival benefit for starting antiretroviral therapy (ART) soon after TB treatment initiation. Current Brazilian guidelines suggest that for patients with a cluster of differentiation 4 (CD4) < 50, ART should be started within 2 weeks of starting TB treatment; for patients with a CD4>50, ART should be started within 2 months of starting TB treatment. World Health Organization guidelines suggest ART initiation within 2 weeks of TB diagnosis regardless of CD4 count (provided there are no signs of TB meningitis), but most programs defer ART until 6-8 weeks in patients with CD4 >50 to reduce the risk of immune reconstitution inflammatory syndrome (IRIS). The option of dual therapy for HIV (i.e., complete regimens to treat HIV composed of only 2 drugs) is of increasing interest and can lower costs for patients, payors, and programs while lowering cumulative lifetime exposure to ART (with potential resultant lessened burden of cumulative toxicities) and maintaining high antiviral efficacy. Based on the GEMINI, TANGO, and SALSA clinical trials, a regimen of 50 milligram (mg) DTG combined with 300mg lamivudine (3TC) has been shown to be a highly effective stand-alone option for the treatment of HIV-1 in ART treatment-naïve or virologically suppressed individuals through 48 weeks (SALSA) and 144 weeks (GEMINI and TANGO).
Johns Hopkins University
6Research sites
150Patients around the world

This study is for people with

Tuberculosis
Hiv

Requirements for the patient

To 99 Years
All Gender

Medical requirements

Documentation of HIV-1 status: HIV-1 infection, documented by any licensed rapid HIV test or HIV-1 enzyme or chemiluminescence immunoassay E/CIA test kit at any time prior to entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, or plasma HIV 1 RNA viral load.
CD4+ cell count ≥50 cells/mm3 obtained within 30 days prior to study entry.
HIV-1 viral load ≥1000 copies/mL.
ART-naïve.
Documentation of pulmonary TB.
Pregnant, or plans to become pregnant.

Sites

Universidade Federal da Bahia
R. Dr. Augusto Viana - Canela, Salvador - BA, 40110-060, Brazil
Fundación Oswaldo Cruz - FIOCRUZ
Av. Brasil, 4365 - Manguinhos, Rio de Janeiro - RJ, 21040-900
Hospital Geral de Nova Iguaçu
Av. Henrique Duque Estrada Meyer - Posse, Nova Iguaçu - RJ, 26030-380
Fundação Universidade de Caxias do Sul
10 de febrero de 1967, Caxias do Sul, Río Grande del Sur
Hospital de Clínicas de Porto Alegre - HCPA/UFRGS
Rua Ramiro Barcelos, 2350, Av. Protásio Alves, 211 - Santa Cecília, Porto Alegre - RS, 90035-903
Faculdade de Medicina da Universidade Estadual Paulista - Campus de Botucatu - UNESP
s/n, Av. Prof. Montenegro - Distrito de, Botucatu - SP, 18618-687
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