Efficacy Study of Different Laboratory Management Strategies and Drug Regimens in HIV-infected Ch… (NCT02028676) | Clinical Trial Compass
CompletedPhase 4
Efficacy Study of Different Laboratory Management Strategies and Drug Regimens in HIV-infected Children in Africa
Uganda, Zimbabwe1,206 participantsStarted 2007-03
Plain-language summary
The two original objectives were to determine in HIV-infected children initiating antiretroviral therapy (ART):
1. Whether clinically driven monitoring (CDM) will have a similar outcome in terms of disease progression or death as routine laboratory and clinical monitoring (LCM) for toxicity (haematology/biochemistry) and efficacy (CD4)?
2. Whether induction with four drugs from two ART classes followed by maintenance with three drugs after 36 weeks be more effective than a continuous non-nucleoside reverse transcriptase inhibitors (NNRTI)-based triple drug regimen in terms of CD4 and clinical outcome?
Two secondary objectives were to determine
3. Whether changing from twice daily lamivudine+abacavir to once daily lamivudine+abacavir after 48 weeks on ART will have a similar outcome in terms of virological suppression and will result in improvements in adherence to ART?
4. Whether stopping daily cotrimoxazole prophylaxis in children over 3 years of age who have been on ART for at least 96 weeks has a similar outcome in terms of hospitalisation or death as continuing daily cotrimoxazole?
Who can participate
Age range
3 Months – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Children should have an adult carer in the household who is either:
. Parents or guardians, and children where appropriate according to age and knowledge of HIV status, must be willing and able to give informed consent for randomisation to CDM or LCM and to first-line ART strategy.
. Participants must have a confirmed documented diagnosis of HIV-1 infection:
. For children aged under 18 months: two separate peripheral blood specimens from different days, both results being positive with HIV-DNA polymerase chain reaction (PCR).
. For children aged 18 months or over: antibody positive serology by ELISA test (confirmed by licensed second ELISA or Western Blot) or WHO approved rapid test (performed in series) both on the same sample. Any child previously tested at another clinic should have a repeat test at an ARROW screening laboratory to confirm their status.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
LCM vs CDM: Disease Progression to a New WHO Stage 4 Event or Death
Timeframe: Median 4 years (from randomization to 16 March 2012; maximum 5 years)
2
LCM vs CDM: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV
Timeframe: Median 4 years (from randomization to 16 March 2012; maximum 5 years)
3
Induction ART: Change From Baseline in CD4% 72 Weeks After ART Initiation
Timeframe: Baseline, 72 weeks
4
Induction ART: Change From Baseline in CD4% to 144 Weeks From ART Initiation
Timeframe: Baseline, 144 weeks
5
Induction ART: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV
Timeframe: Median 4 years (from randomization to 16 March 2012; maximum 5 years)
6
Once Versus Twice Daily Abacavir+Lamivudine: Suppressed HIV RNA Viral Load 48 Weeks After Randomisation
Timeframe: 48 weeks
7
Once Versus Twice Daily Abacavir+Lamivudine: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV, Judged Definitely/Probably or Uncertain Whether Related to Lamivudine or Abacavir
. Age 3 months to 17 years (13-17 years to be capped at 10%)
. ART naïve (except for exposure to perinatal ART for the prevention of mother-to-child HIV transmission).
. Meeting criteria for requiring ART according to WHO stage and CD4 percent or count:
Exclusion criteria
. Cannot, or unlikely to attend regularly (e.g. usual residence too far from study centre)
. Likelihood of poor adherence
. Presence of acute infection (e.g. malaria, helminthiasis, acute hepatitis, acute pneumonia, septicaemia, meningitis). Children may be admitted after recovery of an acute infection. Children with chronic lung disease, including recurrent respiratory infections, are eligible. Children with tuberculosis (TB) will not be enrolled while on the intensive phase of anti-tuberculosis therapy, but should be re-evaluated after the intensive phase and a decision made then about starting ART (see 4 below)
. In receipt of medication contraindicated by ART
. Laboratory abnormalities which are a contra-indication for the child to start ART (haemoglobin \<8.5g/dL; neutrophils \<0.50x109/L; aspartate transaminase (AST) or alanine transaminase (ALT) \>5 x the upper limit of normal (ULN); grade 3 renal dysfunction - creatinine \>1.9 x ULN).
. Being pregnant or breast-feeding an infant
. Perinatal exposure to nevirapine (either through prevention of mother-to-child transmission (pMTCT) or breastfeeding) for children aged 3 - 6 months only
. Participating in ARROW
Timeframe: Median 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years)
8
Cotrimoxazole: New Hospitalisation or Death
Timeframe: Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)
9
Cotrimoxazole: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV
Timeframe: Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)