Human immunodeficiency virus (HIV) Infections and Infestations
Conditions
Interventions
CHAPAS-5 uses a novel design called the Personalized Randomized Controlled Trial (PRACTical) design. This means that each participant will be randomly allocated to receive a treatment from a list that
the trial will end when the last participant to be randomized reaches week 48.
Arm 1: ART naïve and ART experienced participants: dolutegravir/abacavir/lamivudine (DTG/ABC/3TC)
Arm 2: ART naïve and
Sponsors
University College London
Eligibility
Sex/Gender
All
Age
4 Weeks to 15 Years
Inclusion criteria
Inclusion criteria: 1. Aged =4 weeks to <15 years* with confirmed HIV infection 2. Weight =3 kg and <30 kg* 3. Written informed consent obtained (and assent if applicable) 4. Willing to adhere to a minimum of 48 weeks' follow-up *Upper limits of 15 years and 30 kg are for initial treatment options and may be amended when further treatment options are introduced (through a protocol amendment) If antiretroviral therapy (ART)-naive: 1. Planning to start first-line ART 2. Virologically unsuppressed with viral load (VL) =400 copies/ml at screening If ART-experienced: 1. ART-experienced and on DTG-based ART and have been on DTG-based ART for at least 6 months prior to screening 2. Virologically unsuppressed for at least 3 months, demonstrated by two consecutive VLs =400 copies/ml in the last year; the second VL must be at screening 3. Received adherence counselling as per standard practice prior to screening
Exclusion criteria
Exclusion criteria: 1. Alanine aminotransferase (ALT) =5 times the upper limit of normal (ULN), OR both ALT =3 x ULN and bilirubin =2 x ULN at screening** 2. Severe hepatic impairment or unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent jaundice), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) 3. Severe renal impairment, defined as creatinine clearance <30 mL/min/1.73 m², at screening** 4. Severe life-threatening illness (not expected to survive beyond two weeks) as determined by the investigator's clinical judgement 5. Eligible for less than two permitted treatment options based on tables 3 (ART-naive participants) and 4 (ART-experienced participants) 6. Concurrent participation in another clinical trial of an investigational medicinal product (IMP), medical device or other intervention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HIV viral suppression measured using plasma HIV viral load testing, defined as being alive and having an HIV viral load <400 copies/ml, at week 48 (a repeat viral load result will be used if the initial viral load is =400 copies/ml) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. HIV viral suppression measured using plasma HIV viral load testing, defined as being alive and having an HIV viral load <1000 copies/ml at week 48 (a repeat viral load result will be used if the initial viral load is =1000 copies/ml) 2. Cross-sectional HIV viraemia measured using plasma HIV viral load testing, defined as the proportion of participants with HIV viral load =50 copies/ml, =400 copies/ml, and =1000 copies/ml at week 48 (using the viral load measurement closest to the scheduled week 48 visit) 3. Emergent HIV drug resistance measured using HIV drug resistance testing at week 48 4. Serious adverse events, severe adverse events, and antiretroviral treatment (ART)-modifying events measured using adverse event reporting, assessed from baseline to week 48 5. New or recurrent WHO stage 3 or 4 clinical events or death, measured using adverse event reporting and study records, assessed from baseline to week 48 6. Change in CD4 count and CD4 percentage measured using CD4 cell count and CD4 percentage testing at baseline and week 48 7. Change in weight and BMI-for-age measured using weight and height measurements to calculate BMI-for-age at baseline and week 48 | — |
Countries
Mozambique, Uganda, Zimbabwe
Contacts
Public ContactEllen Owen-Powell
Outcome results
None listed