HIV/AIDS Tuberculosis
Conditions
Interventions
Sponsors
AIDS Clinical Trials Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria 1.Receiving care at a PEPFAR-supported site. 2 Documentation of HIV-1 infection acceptable to the local PEPFAR-supported program to allow antiretroviral (ARV) treatment to be initiated or continued. 3 Age more than or equal to 10 years. 4 Ability and willingness of participant or legal guardian/representative to provide informed consent to participate in the study. 5 Expectation that the participant will receive care within the local PEPFARsupported program and will be able to be followed for study evaluations for at least 6 months and ideally for 36 months.
Exclusion criteria
Exclusion criteria: Exclusion Criteria 1. Weight less than 30 kg. 2 For participants already on ART in Groups 1, 2, and 3, known to have had an ART interruption encompassing the entire 14 day window (=14 consecutive days) immediately prior to study entry. 3 For Group 3, if a participant is already taking TLD at the time of study entry, HIV- 1 RNA >1000 copies/mL within the past 9 months while taking TLD with no subsequent HIV-1 RNA =1000 copies/mL. 4 Prior enrollment in any group in this study. 5 For Group 3 participants, already on concomitant TLD and RIF-containing TB treatment prior to study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome Measures For Groups 1, 2, and 4: Virologic success, defined as suppression of plasma HIV-1 RNA to =1000 copies/mL, at 6 months after starting TLD. This will be based on the measurement closest to exactly 6 months (i.e., 183 days) after the date of start of TLD, within the window of 6 months ±3 months (specifically 92 to 274 days, inclusive). For participants experiencing virologic failure (HIV-1 RNA >1000 copies/mL) at 6 months after starting TLD, new DTG resistance mutations defined as those present at the time of virologic failure confirmation that were not present at the time of starting TLD. For Group 3: Virologic success, defined as suppression of plasma HIV-1 RNA to =1000 copies/mL, at the end of concomitant TLD (including an additional daily dose of DTG 50 mg such that DTG is taken twice daily) and RIF-containing TB treatment. This will be the measurement closest to the end of concomitant treatment within the window of 4 weeks (28 days) before the end to 6 months (183 days) after the end, inclusive. For participants experiencing virologic failure (HIV-1 RNA >1000 copies/mL) at the end of concomitant TLD (including an additional daily dose of DTG 50 mg such that DTG is taken twice daily) and RIF-containing TB treatment, new DTG resistance mutations defined as those present at the time of the virologic failure confirmation thatwere not present at the time of starting TLD. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Treatment outcome measure based on the FDA Snapshot algorithm at 6 months, 12 months, 24 months, and 36 months after starting TLD in each of Groups, 1a, 1b, 2a, 2b, and 4; and at the end of concomitant TLD and RIF-containing TB treatment, 12 months, 24 months, and 36 months after starting concomitant TLD and RIFcontaining TB treatment in Group 3. Based on the FDA Snapshot algorithm, participants’ outcomes will be grouped into the following three categories: ? HIV-1 RNA =1000 copies/mL ? HIV-1 RNA >1000 copies/mL (also includes participants who discontinued study/TLD for Other Reasons [e.g., withdrew consent, loss to followup, moved, etc.] while >1000 copies/mL; and participants who changed ART) ? No Virologic Data (participants will be grouped by the following reasons: on study but missing data in window; discontinued study/TLD due to AE or death; discontinued study/TLD for other reasons [e.g., withdrew consent, loss-tofollowup]) 2 Suppression of plasma HIV-1 RNA to =1000 copies/mL at months 12, 24, and 36. 3 Time to confirmed virologic failure (VF), defined as the time from start of TLD to the first HIV-1 RNA >1000 copies/mL at or after 6 months which is confirmed by the next HIV-1 RNA measurement also being >1000 copies/mL (irrespective of the time between the initial and confirmatory measurements provided that they are obtained on different days, and irrespective of ART being received at the times of these measurements). 4 Time to confirmed virologic failure (as defined above) with a new DTG resistance-associated mutation detected in population-based sequencing (i.e., one not present in the last population-based sequence obtained prior to initiating TLD). 5 Time from start of TLD to TLD discontinuation. 6 Time from start of TLD to TLD discontinuation due to toxicity. 7 Summary score of quality of life measure. | — |
Countries
Kenya
Contacts
Public ContactEvans Odipo
Regulatory officer Kemri CGHR
Outcome results
None listed