Ignite Creation Date:
2024-07-17 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06497465
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-07-04
Brief Title:
DolutegravirLamivudine Dual Therapy for ART-naïve People With HIV and TB Receiving Rifampin-based TB Treatment
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Dolutegravir Plus Lamivudine DTG3TC Dual Therapy Versus Dolutegravir With TDF-lamivudine DTG TDF3TC Among Antiretroviral naïve People With HIV and TB Receiving Rifampin-based TB Treatment
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DOVETAIL
Brief Summary:
This will be a Phase IIIb Clinical Trial an international multicenter randomized three-arm non-comparative trial of efficacy safety and tolerability of the dual therapy regimen dolutegravir plus lamivudine either twice daily or DTG3TC Dovato in the morning dolutegravir DTG in the evening versus standard of care SOC twice-daily dolutegravir plus 2 once-daily Nucleoside reverse-transcriptase inhibitors NRTIs tenofovir disoproxil fumarate lamivudine TDF3TC among antiretroviral therapy ART-nave individuals with HIV-1 receiving rifampin-based TB therapy
Detailed Description:
Tuberculosis TB is the most common cause of death in people with HIV worldwide Among patients with HIV the incidence of TB per year is about 5-10 The two diseases are now always treated concurrently in co-infected individuals as there is a survival benefit for starting antiretroviral therapy ART soon after TB treatment initiation Current Brazilian guidelines suggest that for patients with a cluster of differentiation 4 CD4 50 ART should be started within 2 weeks of starting TB treatment for patients with a CD450 ART should be started within 2 months of starting TB treatment World Health Organization guidelines suggest ART initiation within 2 weeks of TB diagnosis regardless of CD4 count provided there are no signs of TB meningitis but most programs defer ART until 6-8 weeks in patients with CD4 50 to reduce the risk of immune reconstitution inflammatory syndrome IRIS
The option of dual therapy for HIV ie complete regimens to treat HIV composed of only 2 drugs is of increasing interest and can lower costs for patients payors and programs while lowering cumulative lifetime exposure to ART with potential resultant lessened burden of cumulative toxicities and maintaining high antiviral efficacy Based on the GEMINI TANGO and SALSA clinical trials a regimen of 50 milligram mg DTG combined with 300mg lamivudine 3TC has been shown to be a highly effective stand-alone option for the treatment of HIV-1 in ART treatment-naïve or virologically suppressed individuals through 48 weeks SALSA and 144 weeks GEMINI and TANGO
The option of dual therapy for HIV ie complete regimens to treat HIV composed of only 2 drugs is of increasing interest and can lower costs for patients payors and programs while lowering cumulative lifetime exposure to ART with potential resultant lessened burden of cumulative toxicities and maintaining high antiviral efficacy Based on the GEMINI TANGO and SALSA clinical trials a regimen of 50 milligram mg DTG combined with 300mg lamivudine 3TC has been shown to be a highly effective stand-alone option for the treatment of HIV-1 in ART treatment-naïve or virologically suppressed individuals through 48 weeks SALSA and 144 weeks GEMINI and TANGO
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None