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Non-nucleoside reverse transcriptase inhibitor

Doravirine for Pediatric HIV

Phase 2

Recruiting

Research Sponsored by Merck Sharp & Dohme Corp.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Body weight is >3 kg to <45 kg

Has treatment history defined as either TN or with documented viral suppression (HIV-1 RNA <50 copies/mL) for ≥3 months on combination antiretroviral therapy (cART)

Must not have

Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or other prohibited therapy

Has any history of malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 predose, week 4 predose, week 8 random, week 12 random, and week 24 predose and 0.5-2 hours postdose

Awards & highlights

No Placebo-Only Group

Summary

This trial is evaluating the safety and efficacy of an experimental drug for HIV in children.

Who is the study for?

This trial is for HIV-infected children from 4 weeks to under 12 years old, weighing less than 45 kg. They must be either new to treatment or have had their virus levels controlled for at least three months without any history of treatment failure. Girls who can have babies must not be pregnant, breastfeeding, and should use birth control or practice abstinence.

What is being tested?

The study tests Doravirine (DOR), an HIV medication, in combination with two other antiretroviral drugs (NRTIs) in young patients. It aims to understand how the body processes DOR and assess its safety over a period of up to six months.

What are the potential side effects?

While specific side effects are not listed here, common ones associated with antiretrovirals like Doravirine may include nausea, headache, fatigue, diarrhea and potential liver issues. The trial will monitor these and other possible adverse reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My weight is between 3 kg and 45 kg.

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I am HIV positive and have been on effective treatment for at least 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking, nor do I need, any drugs that weaken my immune system.

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I have had cancer before.

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I have kidney disease.

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I have an active infection related to AIDS.

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I have an active hepatitis diagnosis.

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I have signs or tests showing pancreatitis.

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I have had a high HIV viral load despite being on HIV medication for over 3 months.

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I am currently being treated for active tuberculosis.

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I cannot take medicine in the form of oral pellets or granules due to a medical condition.

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I have liver disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 predose, week 4 predose, week 8 random, week 12 random, and week 24 predose and 0.5-2 hours postdose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 predose, week 4 predose, week 8 random, week 12 random, and week 24 predose and 0.5-2 hours postdose

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 predose, week 4 predose, week 8 random, week 12 random, and week 24 predose and 0.5-2 hours postdose for reporting.