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Non-Nucleoside Reverse Transcriptase Inhibitor

Darunavir/ritonavir (DRV/r) for Tuberculosis

Phase 4
Recruiting
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at 3t (30 0/7 weeks to 37 6/7 weeks of pregnancy)
Awards & highlights

Study Summary

This trial will study how well drugs for HIV and TB work when given to pregnant and postpartum women.

Eligible Conditions
  • Tuberculosis
  • Human Immunodeficiency Virus Infection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at 2t (20 0/7 weeks to 26 6/7 weeks of pregnancy)
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at 2t (20 0/7 weeks to 26 6/7 weeks of pregnancy) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the curve (AUC) at second trimester (2T)
Area under the curve (AUC) at third trimester (3T)
Area under the curve (AUC) in second trimester (2T)
+12 more
Secondary outcome measures
Birth weight
Efavirenz, lopinavir, atazanavir, darunavir, dolutegravir, and/or raltegravir: AUC at second trimester (2T), third trimester (3T), and postpartum (PP)
Frequency of grade 2 or higher infant adverse events
+14 more

Trial Design

13Treatment groups
Experimental Treatment
Group I: Component 5: Arm 5.3: LPV/rExperimental Treatment1 Intervention
Women post-delivery receiving LPV/r, and their infants
Group II: Component 5: Arm 5.2: DRV/rExperimental Treatment1 Intervention
Women post-delivery receiving DRV/r, and their infants
Group III: Component 5: Arm 5.1: ATV/rExperimental Treatment1 Intervention
Women post-delivery receiving ATV/r, and their infants
Group IV: Component 4: Arm 4.1: Second-line TB treatment drugsExperimental Treatment1 Intervention
Women ≥ 20 weeks gestation receiving at least one of the following second-line TB treatment drugs, and their infants: Levofloxacin (LFX) 750mg - 1000mg q.d. Clofazimine (CFZ) 100mg q.d. Linezolid (LZD) 300mg - 600mg q.d. Bedaquiline (BDQ) 200mg three times per week (t.i.w.) Delamanid (DLM) 100mg b.i.d. Moxifloxacin (MFX) 400mg or 800mg q.d., and at least one other second-line TB treatment drug under study
Group V: Component 3: Arm 3.3: Lopinavir/ritonavir (LPV/r) 800/200 mgExperimental Treatment2 Interventions
Women ≥ 20 weeks gestation receiving first-line TB treatment with at least two of the following TB treatment drugs: isoniazid (INH), rifampin (RIF), rifabutin (RFB), ethambutol (EMB), pyrazinamide (PZA), moxifloxacin (MFX), and receiving lopinavir/ritonavir (LPV/r) 800/200 mg b.i.d., and their infants
Group VI: Component 3: Arm 3.2: ATV/r or DRV/rExperimental Treatment3 Interventions
Women ≥ 20 weeks gestation receiving first-line TB treatment with at least two of the following TB treatment drugs: isoniazid (INH), rifampin (RIF), rifabutin (RFB), ethambutol (EMB), pyrazinamide (PZA), moxifloxacin (MFX), and receiving atazanavir/ritonavir (ATV/r) ≥ 300/100 mg q.d. or darunavir/ritonavir (DRV/r) ≥ 600/100 mg b.i.d., and their infants
Group VII: Component 3: Arm 3.1: Dolutegravir (DTG) 50 mgExperimental Treatment2 Interventions
Women ≥ 20 weeks gestation receiving first-line TB treatment with at least two of the following TB treatment drugs: isoniazid (INH), rifampin (RIF), rifabutin (RFB), ethambutol (EMB), pyrazinamide (PZA), moxifloxacin (MFX), and receiving dolutegravir (DTG) 50 mg twice daily (b.i.d.) when combined with RIF or 50 mg q.d. if RIF is not part of the TB regimen, and their infants
Group VIII: Component 2: Arm 2.1: CAB LAExperimental Treatment1 Intervention
Women ≥ 24 weeks gestation who received at least one dose of long-acting injectable formulation of cabotegravir (CAB LA) any dose during pregnancy, and their infants
Group IX: Component 1: Arm 1.5: TAF 25 mg q.d. with boostingExperimental Treatment3 Interventions
Women ≥ 20 weeks gestation not receiving TB drugs and receiving TAF 25 mg q.d. boosted with cobicistat or ritonavir, and their infants
Group X: Component 1: Arm 1.4: TAF 25 mg q.d. without boostingExperimental Treatment1 Intervention
Women ≥ 20 weeks gestation not receiving TB drugs and receiving TAF 25 mg q.d. without boosting, and their infants
Group XI: Component 1: Arm 1.3: Tenofovir alafenamide (TAF) 10 mg q.d.Experimental Treatment2 Interventions
Women ≥ 20 weeks gestation not receiving TB drugs and receiving tenofovir alafenamide (TAF) 10 mg q.d. boosted with cobicistat, and their infants
Group XII: Component 1: Arm 1.2: Doravirine (DOR) 100 mg q.d.Experimental Treatment1 Intervention
Women ≥ 20 weeks gestation not receiving TB drugs and receiving doravirine (DOR) 100 mg q.d., and their infants
Group XIII: Component 1: Arm 1.1: Bictegravir (BIC) 50 mg q.d.Experimental Treatment1 Intervention
Women ≥ 20 weeks gestation not receiving TB drugs and receiving bictegravir (BIC) 50 mg once daily (q.d.), and their infants
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dolutegravir (DTG)
2016
Completed Phase 4
~1640
Doravirine (DOR)
2019
Completed Phase 2
~70
Lopinavir/ritonavir (LPV/r)
2002
Completed Phase 3
~470
Tenofovir alafenamide (TAF)
2019
Completed Phase 2
~330
Ritonavir
2005
Completed Phase 4
~2200
Cobicistat
2014
Completed Phase 2
~640

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,246 Total Patients Enrolled
8 Trials studying Tuberculosis
2,849 Patients Enrolled for Tuberculosis
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,268 Previous Clinical Trials
5,480,807 Total Patients Enrolled
137 Trials studying Tuberculosis
458,588 Patients Enrolled for Tuberculosis
International Maternal Pediatric Adolescent AIDS Clinical Trials GroupNETWORK
34 Previous Clinical Trials
12,074 Total Patients Enrolled
5 Trials studying Tuberculosis
2,225 Patients Enrolled for Tuberculosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum
2021. "Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04518228.
~132 spots leftby Mar 2026
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