Clinical Trials in Mexico / NCT04375800
Recruiting
Phase 2
Doravirine (DOR) in Human Immunodeficiency Virus (HIV)-Infected Children Aged 4 Weeks to <12 Years and <45 kg (MK-1439-066)
NCT04375800 · tracked via the Priya Life Science Mexico tracker
Condition(s) studied
Human Immunodeficiency Virus (HIV) Infection
Investigational drug(s) / intervention(s)
Doravirine: Administered orally
2 NRTIs: Administered orally
DOR/3TC/TDF: Administered orally
Study summary
This is a single-group, open-label, multi-site study in pediatric participants with human immunodeficiency virus type 1 (HIV-1) infection, aged 4 weeks to \<12 years and weighing \<45 kg, who are treatment-naive (TN) or have been virologically suppressed (VS) on stable combination antiretroviral therapy (cART) for ≥3 months with no history of treatment failure. The primary objectives are:
* To evaluate the steady state pharmacokinetics (PK) of doravirine (DOR) \[MK-1439\] when given in combination with 2 nucleoside/nucleotide analog reverse transcriptase inhibitors (NRTIs) or as part of the fixed-dose combination (FDC) of DOR/lamivudine (3TC)/tenofovir disproxil fumarate (TDF) in participants ≥6 to \<12 years and weighing ≥14 to \<45 kg.
* To evaluate the safety and tolerability of DOR when given with 2 NRTIs or as part of the FDC of DOR/3TC/TDF, in participants ≥6 to 12 years and weighing ≥14 to \<45 kg, through Week 24.
Eligibility
Inclusion Criteria:
* Has human immunodeficiency virus type 1 (HIV-1) infection confirmed at screening
* Has appropriate treatment history defined as treatment-naïve (TN) or with documented virologic suppression (HIV-1 ribonucleic acid \[RNA\] \<50 copies/mL) on stable combination antiretroviral therapy (cART) for ≥3 months
* Body weight is \>3 kg to \<45 kg
* If female, is not pregnant or breastfeeding, and one of the following applies:
* Is not a woman of childbearing potential (WOCBP)
* Is a WOCBP using an acceptable form of contraception, or is abstinent
* If a WOCBP must have a negative pregnancy test (urine or serum) within 24 hours of the first dose of study intervention
Study Extension Inclusion Criteria:
* Has completed the Week 96 visit
* Is considered, in the opinion of the investigator, to have derived benefit from treatment with doravirine (DOR) plus the 2 nucleoside/nucleotide analog reverse transcriptase inhibitor (NRTIs) selected by the investigator, or doravirine/lamivudine/tenofovir disoproxil fumarate (DOR/3TC/TDF), by Week 96 of the study
* Is considered, in the opinion of the investigator, to be a clinically appropriate candidate for additional treatment with DOR regimens (DOR plus 2 NRTIs selected by the investigator or DOR/3TC/TDF)
* Understands the procedures in the study extension and has provided (or have the participant's legally acceptable representative, if applicable, provide) documented informed consent/assent to enter the study extension and continue treatment with DOR regimens (DOR plus 2 NRTIs selected by the investigator or DOR/3TC/TDF) until it is available locally in countries participating in the study or for up to an additional 224 weeks (whichever comes first)
Exclusion Criteria:
* Has evidence of renal disease
* Demonstrates evidence of liver disease
* Has clinical or laboratory evidence of pancreatitis
* Has any history of malignancy
* Has presence of any active acquired immunodeficiency syndrome (AIDS)-defining opportunistic Infection
* Has an active diagnosis of hepatitis, including hepatitis B co-infection
* Has current active tuberculosis and/or is being treated with a rifampicin-containing regimen
* Has a medical condition that precludes absorption or intake of oral pellets/granules
* Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound results of the study or interfere with participating for the entire duration of the study
* Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or other prohibited therapy
* Is currently participating in or has participated in an interventional clinical study with an investigational compound or device from 45 days prior to Day 1 through the treatment period
* Has a documented or known virologic resistance to DOR
* Has any history of viremia (HIV RNA \>1000 copies/mL) after at least 3 months on a non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimen
Primary outcome measure(s)
- Area Under the Concentration-Time Curve (AUC) From 0 to 24 Hours Postdose (AUC0-24hr) of Doravirine (DOR) Following Once-Daily Dosing in Plasma at Steady-State — Intensive pharmacokinetic sampling: at designated timepoints up to 24 hours postdose
Per protocol, intensive pharmacokinetic (PK) sampling includes multiple blood samples collected up to 24 hours postdose at a single visit to determine AUC0-24hr. - Maximum Concentration (Cmax) of DOR Following Once-Daily Dosing in Plasma at Steady-State — Intensive pharmacokinetic sampling: at designated timepoints up to 24 hours postdose
Per protocol, intensive PK sampling includes multiple blood samples collected up to 24 hours postdose at a single visit to determine Cmax. - Concentration at 24 Hours (C24) of DOR Following Once-Daily Dosing in Plasma at Steady-State — Intensive pharmacokinetic sampling: at designated timepoints up to 24 hours postdose
Per protocol, intensive PK sampling includes multiple blood samples collected up to 24 hours postdose at a single visit to determine C24. - Time to Maximum Concentration (Tmax) of DOR Following Once-Daily Dosing in Plasma at Steady-State — Intensive pharmacokinetic sampling: at designated timepoints up to 24 hours postdose
Per protocol, intensive PK sampling includes multiple blood samples collected up to 24 hours postdose at a single visit to determine Tmax. - AUC From 0 to 12 Hours Postdose (AUC0-12hr) of DOR Following Twice-Daily Dosing in Plasma at Steady-State — Intensive pharmacokinetic sampling: at designated timepoints up to 12 hours postdose
Per protocol, intensive PK sampling includes multiple blood samples collected up to 12 hours postdose at a single visit to determine AUC0-12hr. - Cmax of DOR Following Twice-Daily Dosing in Plasma at Steady-State — Intensive pharmacokinetic sampling: at designated timepoints up to 12 hours postdose
Per protocol, intensive PK sampling includes multiple blood samples collected up to 12 hours postdose at a single visit to determine Cmax. - Concentration at 12 Hours (C12) of DOR Following Twice-Daily Dosing in Plasma at Steady-State — Intensive pharmacokinetic sampling: at designated timepoints up to 12 hours postdose
Per protocol, intensive PK sampling includes multiple blood samples collected up to 12 hours postdose at a single visit to determine C12. - Tmax of DOR Following Twice-Daily Dosing in Plasma at Steady-State — Intensive pharmacokinetic sampling: at designated timepoints up to 12 hours postdose
Per protocol, intensive PK sampling includes multiple blood samples collected up to 12 hours postdose at a single visit to determine Tmax. - Percentage of Participants With ≥1 Adverse Event (AE) — Up to 24 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study interventions. - Percentage of Participants With a Grade 3 or 4 AE — Up to 24 weeks
Grade 3 or 4 AEs are "severe symptoms that cause inability to perform usual social and functional activities with intervention or hospitalization indicated" (Grade 3), or "potentially life-threatening events" (Grade 4). - Percentage of Participants With Events of Death — Up to 24 weeks
The percentage of participants with events of death at Week 24 will be reported. - Percentage of Participants Discontinuing From Study Intervention Due to an AE — Up to 24 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study interventions. - Percentage of Participants Discontinuing From Study Intervention Due to a Drug-Related AE — Up to 24 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, that is considered to be related to the study interventions.
Trial sites (24)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Colorado at Denver ( Site 0108) | Aurora | Colorado | Completed |
| Emory Children's Center ( Site 0103) | Atlanta | Georgia | Recruiting |
| Clinica Somer ( Site 1003) | Rionegro | Antioquia | Recruiting |
| Ciensalud Ips S A S ( Site 1001) | Barranquilla | Atlántico | Recruiting |
| CEIP - Centro de Estudios en Infectología Pediátrica ( Site 1002) | Cali | Valle del Cauca Department | Completed |
| Instituto Nacional de Pediatria ( Site 0701) | Coyoacán | Mexico City | Completed |
| Hospital Infantil de Mexico Federico Gomez ( Site 0702) | Mexico City | Mexico City | Active Not Recruiting |
| Unidad de Atencion Medica e Investigacion en Salud S.C. ( Site 0700) | Mérida | Yucatán | Completed |
| Kuzbasskiy Center for the Prevention and Control of AIDS ( Site 0506) | Kemerovo | Kemerovo Oblast | Active Not Recruiting |
| Clinical Centre for Prevention and Control of AIDS ( Site 0504) | Krasnodar | Krasnodarskiy Kray | Completed |
| Krasnoyarsk Regional Center for Prevention and Control of AIDS ( Site 0507) | Krasnoyarsk | Krasnoyarsk Krai | Completed |
| Infectious Clinical Hospital #2 ( Site 0501) | Moscow | Moscow | Completed |
| FGU Republican Clinical Infectious Hospital of Roszdrav ( Site 0500) | Saint Petersburg | Sankt-Peterburg | Active Not Recruiting |
| FARMOVS PTY LTD ( Site 0601) | Bloemfontein | Free State | Completed |
| Perinatal HIV Research Unit ( Site 0602) | Johannesburg | Gauteng | Recruiting |
| Wits Reproductive Health and HIV Institute (WRHI) ( Site 0603) | Johannesburg | Gauteng | Recruiting |
| Empilweni Services and Research Unit ( Site 0604) | Johannesburg | Gauteng | Completed |
| King Edward Hospital ( Site 0600) | Durban | KwaZulu-Natal | Recruiting |
| Family Clinic Research With UBUNTU ( Site 0605) | Cape Town | Western Cape | Recruiting |
| Be Part Yoluntu Centre ( Site 0606) | Paarl | Western Cape | Recruiting |
| Tsitsikamma Clinical Research Initiative (TCRI) ( Site 0607) | Plettenberg Bay | Western Cape | Completed |
| Siriraj Hospital ( Site 0901) | Bangkok | Bangkok | Recruiting |
| Research Institute for Health Sciences ( Site 0902) | Chiang Mai | Thailand | Recruiting |
| Faculty of Medicine - Khon Kaen University ( Site 0903) | Khon Kaen | Thailand | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04375800 on ClinicalTrials.gov ↗ ← All trials in Mexico