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New treatment option for Human Immunodeficiency Virus (HIV) Infection
Official title Doravirine (DOR) in Human Immunodeficiency Virus (HIV)-Infected Children Aged 4 Weeks to <12 Years and <45 kg (MK-1439-066)
ClinicalTrials.gov ID: NCT04375800
What this study is testing
What is Doravirine?
Doravirine is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for human immunodeficiency virus (hiv) infection.
Also referred to as MK-1439.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 4 to 11
You may be able to join if
- 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...
- 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)
You likely can't join if
- 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
See the full eligibility 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
- 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...
- 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...
- 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 treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
- Atlanta, Georgia, United States
- Rionegro, Antioquia, Colombia
- Barranquilla, Atlántico, Colombia
- Cali, Valle del Cauca Department, Colombia
- Coyoacán, Mexico City, Mexico
- Mexico City, Mexico City, Mexico
- Mérida, Yucatán, Mexico
- Kemerovo, Kemerovo Oblast, Russia
- Krasnodar, Krasnodarskiy Kray, Russia
- Krasnoyarsk, Krasnoyarsk Krai, Russia
- Moscow, Moscow, Russia
- Saint Petersburg, Sankt-Peterburg, Russia
- Bloemfontein, Free State, South Africa
- Johannesburg, Gauteng, South Africa
- Durban, KwaZulu-Natal, South Africa
- Cape Town, Western Cape, South Africa
- Paarl, Western Cape, South Africa
- Plettenberg Bay, Western Cape, South Africa
- Bangkok, Bangkok, Thailand
+ 2 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 4 weeks to 11 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States; Atlanta, Georgia, United States; Rionegro, Antioquia, Colombia; Barranquilla, Atlántico, Colombia; Cali, Valle del Cauca Department, Colombia; Coyoacán, Mexico City, Mexico and 16 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.