Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Dolutegravir Plus Tenofovir/Lamivudine or Emtricitabine in HIV-1 Infected Transgender Women (TRANSViiV)

7. august 2019 opdateret af: Omar Sued, Fundación Huésped

Pilot Study of Dolutegravir Plus Tenofovir/Lamivudine or Emtricitabine in HIV-1 Infected Transgender Women

Prospective, open, single-arm trial of dolutegravir-tenofovir and emtricitabine or lamivudine (DTG-TDF-FTC or 3TC) in antiretroviral (ART) naïve HIV transgender women (TGW).

The primary objective of this pilot study is to determine the retention in care of TGW treated with DTG-TDF-FTC or 3TC

Secondary objectives:

  • To evaluate the efficacy of the antiretroviral regimen at week 48 ;
  • To describe the safety and tolerability of this regimen;
  • To evaluate adherence across 48 weeks;
  • To determine the patient satisfaction with this regimen;
  • To identify individual, social and contextual factors associated with adherence and retention.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The primary objective of this pilot study is to determine the retention in care of TGW treated with DTG-TDF-FTC.

The primary objective will be assessed by the proportion of individuals that provide information on ART use and virological outcomes at the end of the study:

  • Retention under care: Proportion of enrolled and dosed individuals that provide clinical information up to 48 weeks of follow up.
  • Retention on treatment: Proportion of enrolled and dosed individuals that receive study drugs up to 48 weeks of follow up.

Secondary objectives:

  • To evaluate the efficacy of the antiretroviral regimen at week 48 ;
  • To describe the safety and tolerability of this regimen;
  • To evaluate adherence across 48 weeks;
  • To determine the patient satisfaction with this regimen;
  • To identify individual, social and contextual factors associated with adherence and retention.

The secondary objectives will be evaluated using the following endpoints:

  1. Proportion of patients with HIV-1 RNA levels of less than 50 copies/mL at 48 weeks of treatment by the IIT-exposed snapshot FDA algorithm;
  2. Frequency, type and severity of adverse events and laboratory abnormalities;
  3. Pill count, analogue visual scale for adherence in each visit;
  4. Changes in the scores of stigma and discrimination scales , quality of life, social support and anxiety and depression (BERGER, WBI,DUKE,CES-D,STAI) at bsl, 4,24, and 48 weeks e;.Changes in the score scales of sexual behaviors, use of drug /alcohol at bsl and at each visit .

f. Through association of baseline individual, social and contextual characteristics with percentage of adherence and retention at 48 weeks.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

60

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Argentina
    • Buenos Aires
      • Ciudad de Buenos Aires, Buenos Aires, Argentina, C1202ABB
        • Fundacion Huesped

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  1. HIV-1 positive serology by at least two different serological tests (rapid test, ELISA, Western Blot) or a viral load higher than 3,000 copies/mL.
  2. 18 years and older.
  3. Self-identified as TGW
  4. ART naïve.
  5. Written informed consent provided.

Exclusion Criteria:

  1. Genotypic resistance to TDF and/or FTC as per IAS-USA resistance panel 2013.
  2. Alcohol or drug use that might affect adherence.
  3. Concomitant use of lipid-lowering drugs, interferon, interleukin-2, cytotoxic chemotherapy, dofetilide (or pilsicainide) or immunosuppressors, antacids drugs containing Ca++ and or Mg++ at study entry.
  4. Opportunistic infection (CDC "C" category) or other disease and/or clinical conditions that, in the investigator's opinion, would compromise the patient's safety or outcome of the study; including malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia.
  5. Treatment with any of the following agents within 28 days of screening: radiation therapy; cytotoxic chemotherapeutic agents; any immunomodulators that alter immune responses or treatment with an HIV-1 immunotherapeutic vaccine within 90 days of screening or exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of the investigational product.
  6. Contraindication to any of the study drugs (history of renal diseases, lab abnormalities grade 4 or any other clinical condition prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements).
  7. Anticipated need for Hepatitis C virus (HCV) therapy during the study.
  8. Creatinine clearance of <50 mL/min via Cockroft-Gault method.
  9. Subjects with moderate to severe hepatic impairment (Class B or greater) as determined by Child-Pugh classification.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: single arm
ARV treatment based on Dolutegravir Plus Tenofovir/Lamivudine or Emtricitabine
Medicin: ARV treatment
Dolutegravir 50 mg QD plus co-formulated emtricitabine 200 mg/tenofovir 300 mg QD.
Andre navne:
  • tivicay-truvada

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of transgender women retained in care at week 48
Tidsramme: 48 weeks

Proportion of enrolled and dosed individuals that complete protocol defined visits during 48 weeks of follow up.

Retention under care: Proportion of enrolled and dosed individuals that provide clinical information up to 48 weeks of follow up.

Retention on treatment: Proportion of enrolled and dosed individuals that receive study drugs up to 48 weeks of follow up.
48 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of individuals with HIV RNA undetectable at week 48
Tidsramme: 48 weeks
Proportion of patients with HIV-1 RNA levels less than 50 copies/mL at week 48 weeks of treatment by the IIT-exposed snapshot FDA algorithm;
48 weeks
Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality
Tidsramme: From baseline to week 48
Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant.
From baseline to week 48
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
Tidsramme: From baseline to week 48
Adverse events (AEs) occurring during treatment and for 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event.
From baseline to week 48
Adherence using ACTG form
Tidsramme: From baseline to week 48
ACTG self report adherence form will be used for baseline and follow up visits
From baseline to week 48
Adherence using analogue visual scale
Tidsramme: From week 4 to week 48
Analogue visual scale (0-10) will be used at each follow up visit
From week 4 to week 48
Adherence by pill count
Tidsramme: From week 4 to week 48
Pill count of dispensed drugs
From week 4 to week 48
Quality of life by QoL Socre and Well being index
Tidsramme: From baseline to week 48
Changes in the scores of quality of life, will be done through Well-being Index questionnaire, this instrument will be administered to patients at baseline, week 4, 24 and week 48 .
From baseline to week 48
Patient´s satisfaction with this regimen
Tidsramme: From baseline to week 48
Changes in the scores of social support,will be done through Duke UNC questionnaire, this instrument will be administered to patients at baseline, week 4, 24 and week 48 .
From baseline to week 48

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Fundación Huésped

Samarbejdspartnere

ViiV Healthcare

Efterforskere

  • Ledende efterforsker: Omar Sued, MD, PhMD, Fundacion Huesped

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2015

Primær færdiggørelse (Faktiske)

28. juni 2019

Studieafslutning (Faktiske)

28. juni 2019

Datoer for studieregistrering

Først indsendt

18. august 2016

Først indsendt, der opfyldte QC-kriterier

24. januar 2017

Først opslået (Skøn)

27. januar 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. august 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. august 2019

Sidst verificeret

1. august 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • FH-17

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

to publish study results

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med HIV-infektioner

Kliniske forsøg med ARV treatment

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Sri Lanka

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner