CompletedPhase 2

Dolutegravir Plus 2 NRTIs, in Treatment-Naïve HIV-2 Infected Subjects

Portugal30 participantsStarted 2017-04-05

Plain-language summary

Multicenter, single-arm, open-label clinical trial to evaluate the efficacy, the safety and the tolerability of 50 mg dolutegravir once daily (q.d.) given in combination with 2 NRTIs backbone in HIV-2 positive, treatment-naïve subjects.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Able to understand and willing to comply with all the requirements of the study, as confirmed by giving voluntary written informed consent for participation.
✓. Male or female gender.
✓. Age ≥ 18 years on the day of signing the informed consent.
✓. HIV-2 positive as determined by a positive result in the respective assay.
✓. CD4 count ≤500 cells/mm3 (in case of undetectable baseline HIV-2 viral load); and/or classified as B- or C-stage, by the HIV disease staging and classification system of Centers for Disease Control and Prevention (CDC); and/or have detectable viral load irrespective of CD4 count; and/or have other medical conditions / co-morbidities in which treatment is considered, according to European AIDS Clinical Society (EACS) and national guidelines;
✓. Naïve to ART including investigational antiretroviral agents .
✓. Considered clinically stable with no signs or symptoms of active infection, at the time of entry into the study (i.e., clinical status and all chronic medications should be unchanged for at least 2 weeks prior to the start of treatment in this study), in the opinion of the investigator.
✓. If woman or man with reproductive potential, agrees to adopt one of the following effective contraceptive methods throughout the study:

Exclusion criteria

✕. History or presence of allergy to the study drugs or their components.
✕. HIV-1 infection or HIV-1/HIV-2 dual infection.
✕. History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate.
✕. Documented or known resistance to DTG and/or NRTIs.
✕. Treatment with systemic immunosuppressive therapy or immune modulators within 30 days prior to treatment in this study or is anticipated to need them during the course of the study.
✕. Requiring or is anticipated to require any of the prohibited medications while in the study (dofetilide, inducers of CYP3A4, including phenobarbital, phenytoin, carbamazepine and rifampicin).
✕. Current (active) diagnosis of tuberculosis.
✕. Alanine aminotransferase (ALT) ≥5 times the upper limit of normal (ULN), or ALT ≥3xULN and bilirubin ≥1.5xULN (with \>35% direct bilirubin).

What they're measuring

Efficacy analysis- treatment efficacy, as measured by the "overall treatment success defined as proportion of patients with "global success" at week 48.

Timeframe: 48 Weeks

Trial details

NCT IDNCT03224338

SponsorBlueclinical, Ltd.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-07-02

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