Tenofovir disoproxil fumarate/lamivudine/dolutegravir (TLD) is being used more widely across the world to treat HIV. This is an observational study (a type of study in which participants are observed and certain outcomes are measured). The aim of this study is to observe how successful TLD is at treating HIV, in the following groups of people: * People switching to TLD, after taking anti-HIV medication that contains a nonnucleoside reverse transcriptase inhibitor (NNRTI) drug (such as Efavirenz or Nevirapine) (Group 1). * People switching to TLD, after taking anti-HIV medication that contains a boosted protease inhibitor (PI) drug (such as Lopinavir or Atazanavir) (Group 2). * People taking TLD and receiving medication for TB that includes the drug rifampicin (RIF) (Group 3). These people must be starting one or both of these medications when they enter the study. * People starting TLD who have not taken anti-HIV medication before (Group 4). Another goal of this study is to use genetic testing of the virus (HIV) to see how often HIV is resistant to TLD. Genetic testing of the virus is one way to see if the TLD medication is not working to treat a person's HIV infection.
Study Type
OBSERVATIONAL
Enrollment
1,339
Les Centres GHESKIO CRS (30022)
Port-au-Prince, Bicentaire, Haiti
GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS (31730)
Port-au-Prince, Haiti
Moi University Clinical Research Center (MUCRC) CRS (12601)
Eldoret, Kenya
Kenya Medical Research Institute/Walter Reed Project Clinical Research Center (KEMRI/WRP) CRS (12501)
Kericho, Kenya
Kisumu Crs (31460)
Kisumu, Kenya
Blantyre CRS (30301)
Blantyre, Malawi
Malawi CRS (12001)
Lilongwe, Malawi
University of the Witwatersrand Helen Joseph (WITS HJH) CRS (11101)
Johannesburg, Gauteng, South Africa
Family Clinical Research Unit (FAM-CUR) CRS (8950)
Cape Town, West Cape, South Africa
University of Cape Town Lung Institute (UCTLI) CRS (31792)
Cape Town, Western Cape, South Africa
...and 4 more locations
Proportion of participants achieving virologic success at 6 months (Groups 1, 2, and 4)
Proportion of participants on TLD at 6 months achieving virologic success, defined as suppression of plasma HIV-1 RNA to ≤1000 copies/mL. 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).
Time frame: 6 months +/- 3 months after starting TLD
Proportion of participants achieving virologic success at end of TLD and RIF-Containing TB Treatment (Group 3)
Proportion of participants achieving virologic success, defined as suppression of plasma HIV-1 RNA to ≤1000 copies/mL at the end of concomitant TLD 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.
Time frame: 4 weeks before to 6 months after end of TLD and RIF-containing TB treatment (expect to end concomitant treatment within 12 months of study entry)
Proportion of participants achieving virologic success
Based on the FDA Snapshot algorithm modified to use the HIV-1 RNA threshold of 1000 copies/mL (instead of the usual 50 copies/mL) 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 RIF-containing TB treatment in Group 3.
Time frame: 6 months, 12 months, 24 months, and 36 months after starting TLD
Proportion of participants with low HIV-1 RNA
Plasma HIV-1 RNA ≤1000 copies/mL
Time frame: 12months, 24 months, and 36 months.
Time to confirmed virologic failure (VF)
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
Time frame: At or after 6 months which is confirmed by the next HIV-1 RNA measurement
Time to confirmed virologic failure with a new DTG resistance-associated mutation
DTG resistance-associated mutation as detected in population-based sequencing. New is a mutation not present in the last population-based sequence obtained prior to initiating TLD).
Time frame: From 0 to 36 months
Time from start of TLD to TLD discontinuation
Time from start of TLD to TLD discontinuation
Time frame: From 0 to 36 months
Time from start of TLD to TLD discontinuation due to toxicity.
Time from start of TLD to TLD discontinuation due to toxicity.
Time frame: From 0 to 36 months
Change in quality of life (QoL)
Change in quality of life (QoL), defined as the difference in the summary scores obtained from the ACTG SF-21 at 6 months from the scores obtained at study entry
Time frame: From study start to 6 months
Time from start of TLD to first occurrence of a targeted clinical event
Time from start of TLD to first occurrence of a targeted clinical event
Time frame: From 0 to 36 months
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