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Latest updates to the HIV+ Safety of High-dose Rifapentine-Isoniazid DDI Clinical Trial page
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- Check4 days agoChange DetectedThe study has been updated to version v2.10.0, replacing the previous version v2.9.7.SummaryDifference0.3%
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- Check32 days agoChange DetectedThe value 'Show more Show more Show more Revision: v2.9.0' has been updated to 'Show less Show less MedlinePlus related topics: HIV Drug Information available for: Isoniazid Rifapentine FDA Drug and Device Resources Show less Design Details Primary Purpose : Treatment Allocation : N/A Interventional Model : Sequential Assignment Interventional Model Description: Group 1A:12 ppts will take DTG 50mg/TDF/FTC once daily + once weekly HP for 12 weeks. Semi-intensive PK for DTG,RPT,INH will be collected per protocol. An interim PK, safety, and HIV VL assessment will be performed to ensure that DTG 50mg once daily is safe and meets PK targets. Group 1B:18 ppts will receive either DTG 50mg or dose adjusted DTG + once weekly HP. Semi-intensive PK for DTG,RPT,INH will be collected per protocol. Group 2: 30 ppts will receive DTG at the same dose and frequency as Group 1B. Sparse PK for DTG, safety labs and HIV VL will be measured per protocol. Group 3: 25 ppts who are HIV tx naive will start DTG 50mg/TDF/3TC daily as a FDC tablet + standard of care isoniazid preventive therapy. ART and IPT will start together. Sparse PK for DTG will be collected per protocol. Group 4: 50 ppts who are HIV treatment naive will start DTG 50mg/TDF/3TC daily as a FDC tablet + weekly HP for 12 weeks. ART and 3HP will start together. Sparse PK for DTG will be collected per protocol. Show less Masking : None (Open Label) Arms and Interventions Participant Group/Arm Intervention/Treatment Experimental : Groups 1,2,3 and 4 Group 1: The first 12 participants (Group 1A) will undergo semi-intensive PK sampling and will be key to determining whether an increased dosing of dolutegravir is required in groups 1B. Group 1B will receive dolutegravir at the new dose (if applicable) and will also undergo semi-intensive PK sampling. All will undergo safety and HIV VL assessments. 3HP plus DTG +2NRTIs Group 2: The next 30 (Group 2) will receive dolutegravir at the new dose and will only have sparse PK sampling. All will undergo safety and HIV VL assessments. 3HP plus DTG +2NRTIs Group 3: The next 25 (Group 3) will receive dolutegravir at the same dose as Group 2 and will only have sparse PK sampling. All will undergo safety and HIV VL assessments. IPT plus DTG +2NRTIs Group 4: The next 50 (Group 4) will receive dolutegravir at the same dose as Group 2 and will only have sparse PK sampling. All will undergo safety and HIV VL assessments. 3HP plus DTG +2NRTIs Combination Product : 3HP plus DTG +2NRTIs HIV treatment: DTG will be dosed as described above and will be given with daily TDF/FTC (Groups 1 and 2) or with TDF/3TC (Groups 3 and 4). LTBI treatment: 3HP will be given once-weekly for a total of 12 doses, with doses as follows: Rifapentine: 900 mg; Isoniazid: 900 mg (Groups 1,2 and 4) Isoniazid at standard of care dosing (Group 3)SummaryDifference55%
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