In LATA we will compare two different ways of taking HIV medicines. In the trial you are randomised, with an equal chance that you will either go into the long-acting injectable group or get a daily tablet by mouth. This is what happens depending on which group you are randomised to:

• Long-Acting Injectable Group: In this group, there are 2 options. The first is to stay on your current HIV medicines by mouth and then to start the injections around 4 weeks after randomisation. If this is the choice, then at week 4, the first 2 injections will be given, the second t o ill be given 4 ee s later, and then it’s every 8 ee s from then on. The second option is to switch to taking one tablet of cabotegravir and one tablet of rilpivirine for approximately 4-5 weeks before starting the injections. The reason that some people might choose to have the tablet forms first, is to make sure they tolerate them. This is called an oral lead-in (OLI). For the OLI group, and as long as liver test results at 4 weeks are within normal levels, the first two injections will be given at around 5 weeks (about a week after the week 4 visit), the second two are given 4 weeks later, and then it’s every 8 ee s from then on.

• Continuous Oral Treatment Group: this group will continue to take all their HIV medicines every day by mouth. However, to join the trial, some participants will have to change some of their oral medications as the combination being used is dolutegravir with tenofovir plus either lamivudine or emtricitabine as a single tablet taken once a day, called TLD.

SUMMARY INFORMATION 

LATA (Long-Acting Treatment in Adolescents)

Long-Acting Treatment in Adolescents (LATA) - A randomised open-label 2-arm 96 week trial in virologically suppressed HIV-1-positive adolescents aged 12-19 years of age in Sub-Saharan Africa

 

 

Study Design

Open-label, randomised (1:1), 2-arm, multicentre, 96 weeks, non-inferiority trial

 

Participant population

Adolescents aged 12 to 19 years of age living with HIV-1 who are not pregnant or breastfeeding, and are virologically-suppressed (HIV-1 RNA <50 copies/mL) for at least one year, without any known history of treatment failure, on a 3-drug combination ART consisting of an anchor drug with a 2-drug nucleos(t)ide reverse transcriptase inhibitor (NRTI) backbone

 

Setting

Kenya, South Africa, Uganda and Zimbabwe

 

Interventions to be Compared

Continuous Therapy (CT) control group: Control group is continuous daily oral combination ART consisting of dolutegravir (DTG), with a tenofovir (TFV) and lamivudine(3TC)/emtricitabine(FTC) backbone

Long Acting (LA) injectable group: Intervention group is long-acting injectable, cabotegravir (CAB) LA and rilpivirine (RPV) LA given every 8-weeks after an optional 4-week oral lead-in period with oral cabotegravir and rilpivirine, and two loading doses separated by 4 weeks.

 

Study Hypothesis

CAB LA + RPV LA therapy will provide non-inferior sustained virological suppression compared to continuous treatment with DTG + TFV and 3TC or FTC

 

Primary Outcome Measure(s)

The proportion of participants with confirmed virological rebound, defined as 2 consecutive plasma HIV-RNA ≥50 copies/mL at any time up to the 96-week assessment

 

Secondary Outcome Measure(s)

Efficacy

(i) Proportions of participants with HIV-RNA ≥50 copies/mL at 48 and 96 weeks using a modified FDA snapshot algorithm

(ii) The proportion of participants with HIV-RNA ≥1000 copies/mL (confirmed) by week 96

(iii) The proportion of participants with HIV-RNA ≥200 copies/mL (confirmed) by week 96

(iv) The number and type of HIV mutations (reverse transcriptase and integrase) in participants with confirmed virological rebound

(v) HIV-RNA <50 copies/mL at 24, 48 and 96 weeks