National Institute of Allergy and Infectious Diseases (NIAID)
Who can join
Adults 18 to 65, any sex, with HIV Infection or LTBI. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
DTG PK Parameter Maximum Plasma Concentration (Cmax) Determined Based on DTG Levels From Individual Participants in Arm 1 by Visit DayPrimary· Intensive DTG PK samples at pre-dose, 1h, 2h, 4h, 8h, 12h, 13h, 14h, 23h and 24h post-dose at days 0 and 28
This evaluates the effect of RPT on the DTG PK parameter Cmax obtained from participants enrolled in Arm 1 at day 0 (DTG QD) and day 28 (DTG BID with 1HP). Cmax defines the model-predicted maximum concentration observed over the 12- or 24- hours of the DTG dosing interval.
Day 0
Group
Value
95% CI
Arm 1: DTG + INH + RPT
4180.8
3920.6 – 5196.4
Day 28
Group
Value
95% CI
Arm 1: DTG + INH + RPT
3913.5
3475.7 – 4743.1
DTG PK Parameter Area Under the Concentration Time Curve (AUC0-24) Calculated Based on Intensive PK Samples Obtained From Individual Participants Enrolled in Arm 1 by Visit DayPrimary· Intensive DTG PK samples at pre-dose, 1h, 2h, 4h, 8h, 12h, 13h, 14h, 23h and 24h post-dose at days 0 and 28
This evaluates the effect of RPT on the DTG PK parameter AUC 0-24h obtained from participants enrolled in Arm 1 at day 0 (DTG QD) and day 28 (DTG BID with 1HP). AUC 0-24h defines area under the concentration-time curve over the period of 24 hours post-dose estimated based on the fitted model. For Arm 1, Day 28 (BID dosing), participant-specific AUC0-24h was estimated by summing participant-specific estimated AUC values for the 0-12 hour dosing interval (AUC0-12).
Day 0
Group
Value
95% CI
Arm 1: DTG + INH + RPT
68079.5
59139.5 – 85561.0
Day 28
Group
Value
95% CI
Arm 1: DTG + INH + RPT
65261.3
56748.6 – 81999.4
DTG PK Parameter Minimum Plasma Concentration (Cmin) Determined Based on DTG Levels From Individual Participants in Arm 1 by Visit DayPrimary· Intensive DTG PK samples at pre-dose, 1h, 2h, 4h, 8h, 12h, 13h, 14h, 23h and 24h post-dose at days 0 and 28
This evaluates the effect of RPT on the DTG PK parameter Cmin obtained from participants enrolled in Arm 1 at day 0 (DTG QD) and day 28 (DTG BID with 1HP). Cmin defines the model-predicted minimum concentration observed over the 12- or 24- hour DTG dosing interval.
Day 0
Group
Value
95% CI
Arm 1: DTG + INH + RPT
1726.1
1267.9 – 2395.6
Day 28
Group
Value
95% CI
Arm 1: DTG + INH + RPT
1717.5
1206.6 – 2502.7
DTG PK Parameter Ctrough Determined Based on DTG Levels From Individual Participants in Arm 1 at Day 28Primary· Intensive DTG PK samples at pre-dose, 1h, 2h, 4h, 8h, 12h, 13h, 14h, 23h and 24h post-dose at day 28
This evaluates the effect of RPT on the DTG PK parameter Ctrough obtained from participants enrolled in Arm 1 at day 28 (DTG BID with 1HP). Ctrough defines the observed non-model based minimum concentration observed over the 12- hour DTG dosing interval.
Group
Value
95% CI
Arm 1: DTG + INH + RPT
1987.0
1331.0 – 2377.5
Percentage of Participants in Arm 1 With an Occurrence of Grade 2 or Higher Adverse EventSecondary· From initiation of study treatment to day 28
Arm 1 participants with an occurrence of an adverse event (laboratory value, sign/symptom, diagnosis) of grade 2 or higher on a scale of 1 to 5 where 5 is the most severe. Severity graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017. Participants were counted once at the highest grade.
Grade 2 Adverse Event
Group
Value
95% CI
Arm 1: DTG + INH + RPT
36
21 – 54
Grade 3 Adverse Event
Group
Value
95% CI
Arm 1: DTG + INH + RPT
6
1 – 19
Percentage of Participants in Arm 1 Who Completed the StudySecondary· From initiation of study to day 28
Percentage of participants in Arm 1 who completed the study
Group
Value
95% CI
Arm 1: DTG + INH + RPT
89
74 – 97
Percentage of Participants in Arm 1 Who Completed Study Drug TreatmentSecondary· From initiation of study treatment to day 28
Percentage of participants in Arm 1 who completed study drug treatment (DTG+1HP)
Group
Value
95% CI
Arm 1: DTG + INH + RPT
92
78 – 98
Percentage of Participants in Arm 1 With HIV-1 RNA Levels >50 Copies/mLSecondary· Measured at Days 28 and 42
This evaluates the short-term impact on virologic suppression of DTG based ART when coadministered with 1HP by measuring the percentage of participants with plasma HIV-1 RNA levels \>50 copies/mL at study day 28 (after 4 weeks of DTG+1HP) and study day 42 (14 days after completing study treatment).
Percentage with HIV-1 RNA >50 copies/mL at day 28
Group
Value
95% CI
Arm 1: DTG + INH + RPT
3
Percentage with HIV-1 RNA >50 copies/mL at day 42
Group
Value
95% CI
Arm 1: DTG + INH + RPT
0
Adverse events — posted to ClinicalTrials.gov
Time frame: From start of study treatment to study completion at Day 49 or premature study discontinuation..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study evaluated the potential drug-drug interactions between dolutegravir (DTG) and steady state rifapentine (RPT) when RPT was given with isoniazid (INH) daily for 4 weeks (1HP) as part of treatment for latent TB infection (LTBI) in HIV-1 and LTBI co-infected individuals.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06787976 — Effect of Dolutegravir Compared With Darunavir/Cobicistat on the Severity of Neuropsychiatric Effects al 12 Weeks in Ant
· Phase 4
· not yet recruiting
NCT04518228 — Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum
· completed
NCT04019873 — 'COMBINE-2': Real-world Evidence for Effectiveness of Two Drug Regimen, Antiretroviral Therapy With Integrase Inhibitors
· completed
NCT03539224 — Antiretroviral Treatment Guided by Proviral Genotype: Pilot Trial of Proof of Concept.
· Phase 2
· unknown
NCT02831673 — An Efficacy, Safety, and Tolerability Study Comparing Dolutegravir Plus Lamivudine With Dolutegravir Plus Tenofovir/Emtr
· Phase 3
· completed
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Other National Institute of Allergy and Infectious Diseases (NIAID) trials
Trials by the same sponsor.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID)
Last refreshed: 19 September 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04272242.