Trial · NCT02028676

Efficacy Study of Different Laboratory Management Strategies and Drug Regimens in HIV-infected Children in Africa

NCT02028676, Phase 4, Completed, Medical Research Council; results first posted 2014-06-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy Study of Different Laboratory Management Strategies and Drug Regimens in HIV-infected Children in Africa. Trials, record NCT02028676. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02028676

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy Study of Different Laboratory Management Strategies and Drug Regimens in HIV-infected Children in Africa
NCT number: NCT02028676
Status: Completed
Phases: Phase 4
Enrollment: 1,206 participants, actual
Lead sponsor: Medical Research Council
Conditions: Human Immunodeficiency Virus
Interventions: Clinically Driven Monitoring (CDM), Laboratory plus Clinical Monitoring (LCM), Arm A: ABC+3TC+NNRTI, Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI maintenance, Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC maintenance, Once-daily ABC+3TC, Twice-daily ABC+3TC, Continued cotrimoxazole prophylaxis, Stopped cotrimoxazole prophylaxis
First posted: 2014-01-07
Last updated: 2014-06-06
Other registries' IDs: isrctn:ISRCTN24791884
Results first posted: 2014-06-06

Source ClinicalTrials.gov

Registered outcomes58

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	LCM vs CDM: Disease Progression to a New WHO Stage 4 Event or Death	Median 4 years (from randomization to 16 March 2012; maximum 5 years)	Number of participants with disease progression to a new WHO stage 4 event or death, to be analysed using time-to-event methods
Primary	LCM vs CDM: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV	Median 4 years (from randomization to 16 March 2012; maximum 5 years)	Number of participants with a new Grade 3 or 4 adverse event (AE), not solely related to HIV, to be analysed using time-to-event methods
Primary	Induction ART: Change From Baseline in CD4% 72 Weeks After ART Initiation	Baseline, 72 weeks
Primary	Induction ART: Change From Baseline in CD4% to 144 Weeks From ART Initiation	Baseline, 144 weeks
Primary	Induction ART: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV	Median 4 years (from randomization to 16 March 2012; maximum 5 years)	Number of participants with a new grade 3 or 4 adverse event (AE), not solely related to HIV, to be analysed using time-to-event methods
Primary	Once Versus Twice Daily Abacavir+Lamivudine: Suppressed HIV RNA Viral Load 48 Weeks After Randomisation	48 weeks	Number of participants with HIV RNA viral load \<80 copies/ml at 48 weeks. Measured retrospectively on stored plasma specimens: due to low stored volumes from some children, samples had to be diluted and therefore a threshold of \<80 copies/ml was used to indicate suppression.
Primary	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	Median 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years)	Number of participants with a new grade 3 or 4 adverse event (AE), not solely related to HIV, judged definitely/probably or uncertain whether related to lamivudine or abacavir, to be analysed using time-to-event methods
Primary	Cotrimoxazole: New Hospitalisation or Death	Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)	Number of participants with a new hospitalisation or death, to be analysed using time-to-event methods
Primary	Cotrimoxazole: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV	Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)	Number of participants with a new grade 3 or 4 adverse event (AE), not solely related to HIV, to be analysed using time-to-event methods
Secondary	LCM vs CDM, Induction ART: All-cause Mortality	Median 4 years (from randomization to 16 March 2012; maximum 5 years)	Number of participants who died from any cause, to be analysed using time-to-event methods

1 to 10 of 58Source ClinicalTrials.gov

See all 58 registered outcomes

Outcomes58

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	LCM vs CDM: Disease Progression to a New WHO Stage 4 Event or Death	Median 4 years (from randomization to 16 March 2012; maximum 5 years)	All randomized participants (time-to-event)	participants	NUMBER
PRIMARY	LCM vs CDM: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV	Median 4 years (from randomization to 16 March 2012; maximum 5 years)		participants	NUMBER
PRIMARY	Induction ART: Change From Baseline in CD4% 72 Weeks After ART Initiation	Baseline, 72 weeks	All participants alive at 72 weeks with CD4 measured (completeness in those in follow-up was 96.6%).	percentage of total lymphocytes	MEAN
PRIMARY	Induction ART: Change From Baseline in CD4% to 144 Weeks From ART Initiation	Baseline, 144 weeks	All participants alive in follow-up with CD4% (95% completeness)	percentage of total lymphocytes	MEAN
PRIMARY	Induction ART: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV	Median 4 years (from randomization to 16 March 2012; maximum 5 years)		participants	NUMBER
PRIMARY	Once Versus Twice Daily Abacavir+Lamivudine: Suppressed HIV RNA Viral Load 48 Weeks After Randomisation	48 weeks	All randomized participants with VL result from stored plasma specimen (available for 661/669, 99%, randomized participants)	participants	NUMBER
PRIMARY	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	Median 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years)		participants	NUMBER
PRIMARY	Cotrimoxazole: New Hospitalisation or Death	Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)		participants	NUMBER
PRIMARY	Cotrimoxazole: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV	Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)		participants	NUMBER
SECONDARY	LCM vs CDM, Induction ART: All-cause Mortality	Median 4 years (from randomization to 16 March 2012; maximum 5 years)		participants	NUMBER

1 to 10 of 58Source ClinicalTrials.gov

See all 58 outcomes

Results by group162

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
LCM vs CDM: Disease Progression to a New WHO Stage 4 Event or Death	Clinically Driven Monitoring (CDM)	47		participants
LCM vs CDM: Disease Progression to a New WHO Stage 4 Event or Death	Laboratory Plus Clinical Monitoring (LCM)	39		participants
LCM vs CDM: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV	Clinically Driven Monitoring (CDM)	283		participants
LCM vs CDM: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV	Laboratory Plus Clinical Monitoring (LCM)	282		participants
Induction ART: Change From Baseline in CD4% 72 Weeks After ART Initiation	Arm A: ABC+3TC+NNRTI	16.4	Standard Error 0.45	percentage of total lymphocytes
Induction ART: Change From Baseline in CD4% 72 Weeks After ART Initiation	Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance	17.1	Standard Error 0.43	percentage of total lymphocytes
Induction ART: Change From Baseline in CD4% 72 Weeks After ART Initiation	Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance	17.3	Standard Error 0.41	percentage of total lymphocytes
Induction ART: Change From Baseline in CD4% to 144 Weeks From ART Initiation	Arm A: ABC+3TC+NNRTI	19.8	Standard Error 0.44	percentage of total lymphocytes
Induction ART: Change From Baseline in CD4% to 144 Weeks From ART Initiation	Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance	19.6	Standard Error 0.49	percentage of total lymphocytes
Induction ART: Change From Baseline in CD4% to 144 Weeks From ART Initiation	Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance	19.2	Standard Error 0.46	percentage of total lymphocytes

1 to 10 of 162Source ClinicalTrials.gov

See all 162 results by group

Participant flow108

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Initial Enrolment: CDM vs LCM	STARTED	Clinically Driven Monitoring (CDM)	606
Initial Enrolment: CDM vs LCM	STARTED	Laboratory Plus Clinical Monitoring (LCM)	600
Initial Enrolment: CDM vs LCM	STARTED	Arm A: Abacavir (ABC)+Lamivudine (3TC)+NNRTI	0
Initial Enrolment: CDM vs LCM	STARTED	Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance	0
Initial Enrolment: CDM vs LCM	STARTED	Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance	0
Initial Enrolment: CDM vs LCM	STARTED	Once-daily ABC+3TC	0
Initial Enrolment: CDM vs LCM	STARTED	Twice-daily ABC+3TC	0
Initial Enrolment: CDM vs LCM	STARTED	Continued Cotrimoxazole Prophylaxis	0
Initial Enrolment: CDM vs LCM	STARTED	Stopped Cotrimoxazole Prophylaxis	0
Initial Enrolment: CDM vs LCM	COMPLETED	Clinically Driven Monitoring (CDM)	606

1 to 10 of 108Source ClinicalTrials.gov

See all 108 participant flow

Adverse events333

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaemia with no clinical symptoms	Infections and infestations	Clinically Driven Monitoring (CDM)	29	606	32
other	Anaemia with no clinical symptoms	Infections and infestations	Laboratory Plus Clinical Monitoring (LCM)	37	600	41
other	Anaemia with no clinical symptoms	Infections and infestations	Arm A: Abacavir (ABC)+Lamivudine (3TC)+NNRTI	20	397	22
other	Anaemia with no clinical symptoms	Infections and infestations	Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance	22	404	26
other	Anaemia with no clinical symptoms	Infections and infestations	Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance	24	405	25
other	Anaemia with no clinical symptoms	Infections and infestations	Once-daily ABC+3TC	3	336	3
other	Anaemia with no clinical symptoms	Infections and infestations	Twice-daily ABC+3TC	5	333	7
other	Anaemia with no clinical symptoms	Infections and infestations	Continued Cotrimoxazole Prophylaxis	5	376	5
other	Anaemia with no clinical symptoms	Infections and infestations	Stopped Cotrimoxazole Prophylaxis	5	382	5
other	Neutropenia with no clinical symptoms	Investigations	Clinically Driven Monitoring (CDM)	151	606	211

1 to 10 of 333Source ClinicalTrials.gov

See all 333 adverse events

Adverse event totals27

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Clinically Driven Monitoring (CDM)
Total, all-cause mortality	Laboratory Plus Clinical Monitoring (LCM)
Total, all-cause mortality	Arm A: Abacavir (ABC)+Lamivudine (3TC)+NNRTI
Total, all-cause mortality	Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance
Total, all-cause mortality	Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance
Total, all-cause mortality	Once-daily ABC+3TC
Total, all-cause mortality	Twice-daily ABC+3TC
Total, all-cause mortality	Continued Cotrimoxazole Prophylaxis
Total, all-cause mortality	Stopped Cotrimoxazole Prophylaxis
Total, other adverse events	Clinically Driven Monitoring (CDM)	190	606

1 to 10 of 27Source ClinicalTrials.gov

See all 27 adverse event totals

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
23473847	RESULT	PubMed
24382064	RESULT	PubMed
27064996	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons22

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Continued Cotrimoxazole Prophylaxis vs Stopped Cotrimoxazole Prophylaxis: Cotrimoxazole: New WHO Stage 3 or 4 Event or Death	Trial comparisons
Continued Cotrimoxazole Prophylaxis vs Stopped Cotrimoxazole Prophylaxis: Cotrimoxazole: New WHO Stage 4 Event or Death	Trial comparisons
Once-daily ABC+3TC vs Twice-daily ABC+3TC: Once Versus Twice Daily Abacavir+Lamivudine: All-cause Mortality	Trial comparisons
Continued Cotrimoxazole Prophylaxis vs Stopped Cotrimoxazole Prophylaxis: Cotrimoxazole: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV	Trial comparisons
Once-daily ABC+3TC vs Twice-daily ABC+3TC: Once Versus Twice Daily Abacavir+Lamivudine: New WHO Stage 3 or 4 Event or Death	Trial comparisons
Continued Cotrimoxazole Prophylaxis vs Stopped Cotrimoxazole Prophylaxis: Cotrimoxazole: New WHO Stage 3 Severe Recurrent Pneumonia or Diarrhoea	Trial comparisons
Once-daily ABC+3TC vs Twice-daily ABC+3TC: Once Versus Twice Daily Abacavir+Lamivudine: New WHO Stage 4 Event or Death	Trial comparisons
Once-daily ABC+3TC vs Twice-daily ABC+3TC: Once Versus Twice Daily Abacavir+Lamivudine: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV	Trial comparisons
Clinically Driven Monitoring (CDM) vs Laboratory Plus Clinical Monitoring (LCM): LCM vs CDM: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV	Trial comparisons
Once-daily ABC+3TC vs Twice-daily ABC+3TC: Once Versus Twice Daily Abacavir+Lamivudine: New Serious Adverse Events Not Solely Related to HIV	Trial comparisons

1 to 10 of 22

See all 22 trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02028676

GET https://conductscience.org/api/trials/v1/NCT02028676/registered?page=2

API reference For AI assistants