Trial Outcomes & Findings for Optimizing Pediatric HIV-1 Treatment in Infants With Prophylactic Exposure to Nevirapine, Nairobi, Kenya (NCT NCT00427297)
NCT ID: NCT00427297
Last Updated: 2018-08-27
Results Overview
Death during follow-up
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
34 participants
Primary outcome timeframe
2 years
Results posted on
2018-08-27
Participant Flow
Participant milestones
| Measure |
NVP-containing
Infants randomized to this arm will receive nevirapine-containing HAART regimen
AZT/3TC/NVP (zidovudine/lamivudine/nevirapine): First line regimen
d4T/3TC/NVP (stavudine/lamivudine/nevirapine): First line regimen
ABC/3TC/NVP (abacavir/lamivudine/nevirapine): First line regimen
|
NVP-sparing
Infants randomized to this arm will receive nevirapine-sparing HAART
AZT/3TC/ABC (zidovudine/lamivudine/abacavir): First line regimen
d4T/3TC/ABC (stavudine/lamivudine/abacavir): First line regimen For children who have anaemia(Hb of\<8g/dl), AZT will be substituted for d4T.
ddI/ABC/LPV/r (didanosine/abacavir/lopinavir-ritonavir): Second line regimen
ABC/ ddI or TDF / NVP or EFV (abacavir / didanosine or tenofovir / nevirapine or efavirenz): Second line regimen - Among children randomized to NVP sparing HAART, who will be initiated on a regimen containing lopinavir/ritonavir, zidovudine and lamivudine will be substituted with abacavir and didanosine or tenofovir (TDF) and lopinavir/ ritonavir will be replaced with nevirapine or efavirenz (EFV) in case of treatment failure of the LPV/r containing regimen.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
|
Overall Study
COMPLETED
|
17
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Optimizing Pediatric HIV-1 Treatment in Infants With Prophylactic Exposure to Nevirapine, Nairobi, Kenya
Baseline characteristics by cohort
| Measure |
NVP-containing
n=17 Participants
Infants randomized to this arm will receive nevirapine-containing HAART regimen
AZT/3TC/NVP (zidovudine/lamivudine/nevirapine): First line regimen
d4T/3TC/NVP (stavudine/lamivudine/nevirapine): First line regimen
ABC/3TC/NVP (abacavir/lamivudine/nevirapine): First line regimen
|
NVP-sparing
n=17 Participants
Infants randomized to this arm will receive nevirapine-sparing HAART
AZT/3TC/ABC (zidovudine/lamivudine/abacavir): First line regimen
d4T/3TC/ABC (stavudine/lamivudine/abacavir): First line regimen For children who have anaemia(Hb of\<8g/dl), AZT will be substituted for d4T.
ddI/ABC/LPV/r (didanosine/abacavir/lopinavir-ritonavir): Second line regimen
ABC/ ddI or TDF / NVP or EFV (abacavir / didanosine or tenofovir / nevirapine or efavirenz): Second line regimen - Among children randomized to NVP sparing HAART, who will be initiated on a regimen containing lopinavir/ritonavir, zidovudine and lamivudine will be substituted with abacavir and didanosine or tenofovir (TDF) and lopinavir/ ritonavir will be replaced with nevirapine or efavirenz (EFV) in case of treatment failure of the LPV/r containing regimen.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
7 months
n=5 Participants
|
8 months
n=7 Participants
|
7 months
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
Kenya
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
CD4%
|
22 percentage of cells
n=5 Participants
|
18 percentage of cells
n=7 Participants
|
21.5 percentage of cells
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Analysis was conducted at DSMB termination of study with 15.6 person-years of follow-up time in the cohort overall; 8.5 person-years in NVP-containing and 7.1 person-years in NVP-sparing arm.
Death during follow-up
Outcome measures
| Measure |
NVP-containing
n=17 Participants
Infants randomized to this arm will receive nevirapine-containing HAART regimen
AZT/3TC/NVP (zidovudine/lamivudine/nevirapine): First line regimen
d4T/3TC/NVP (stavudine/lamivudine/nevirapine): First line regimen
ABC/3TC/NVP (abacavir/lamivudine/nevirapine): First line regimen
|
NVP-sparing
n=17 Participants
Infants randomized to this arm will receive nevirapine-sparing HAART
AZT/3TC/ABC (zidovudine/lamivudine/abacavir): First line regimen
d4T/3TC/ABC (stavudine/lamivudine/abacavir): First line regimen For children who have anaemia(Hb of\<8g/dl), AZT will be substituted for d4T.
ddI/ABC/LPV/r (didanosine/abacavir/lopinavir-ritonavir): Second line regimen
ABC/ ddI or TDF / NVP or EFV (abacavir / didanosine or tenofovir / nevirapine or efavirenz): Second line regimen - Among children randomized to NVP sparing HAART, who will be initiated on a regimen containing lopinavir/ritonavir, zidovudine and lamivudine will be substituted with abacavir and didanosine or tenofovir (TDF) and lopinavir/ ritonavir will be replaced with nevirapine or efavirenz (EFV) in case of treatment failure of the LPV/r containing regimen.
|
|---|---|---|
|
Incidence of Mortality
|
4 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: 15.6 person years of follow-up overall at time of DSMB closure of study
Immunologic treatment failure was defined as CD4% dropping below 15%, after a previous result greater than or equal to 15% (following along WHO Guidelines).
Outcome measures
| Measure |
NVP-containing
n=12 Participants
Infants randomized to this arm will receive nevirapine-containing HAART regimen
AZT/3TC/NVP (zidovudine/lamivudine/nevirapine): First line regimen
d4T/3TC/NVP (stavudine/lamivudine/nevirapine): First line regimen
ABC/3TC/NVP (abacavir/lamivudine/nevirapine): First line regimen
|
NVP-sparing
n=13 Participants
Infants randomized to this arm will receive nevirapine-sparing HAART
AZT/3TC/ABC (zidovudine/lamivudine/abacavir): First line regimen
d4T/3TC/ABC (stavudine/lamivudine/abacavir): First line regimen For children who have anaemia(Hb of\<8g/dl), AZT will be substituted for d4T.
ddI/ABC/LPV/r (didanosine/abacavir/lopinavir-ritonavir): Second line regimen
ABC/ ddI or TDF / NVP or EFV (abacavir / didanosine or tenofovir / nevirapine or efavirenz): Second line regimen - Among children randomized to NVP sparing HAART, who will be initiated on a regimen containing lopinavir/ritonavir, zidovudine and lamivudine will be substituted with abacavir and didanosine or tenofovir (TDF) and lopinavir/ ritonavir will be replaced with nevirapine or efavirenz (EFV) in case of treatment failure of the LPV/r containing regimen.
|
|---|---|---|
|
Immunologic Failure
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: 15.6 person years of follow-up overall at time of DSMB closure of study
Virologic treatment failure was defined as follow-up (at least 24 weeks after enrollment date) viral load \> 400 copies.
Outcome measures
| Measure |
NVP-containing
n=8 Participants
Infants randomized to this arm will receive nevirapine-containing HAART regimen
AZT/3TC/NVP (zidovudine/lamivudine/nevirapine): First line regimen
d4T/3TC/NVP (stavudine/lamivudine/nevirapine): First line regimen
ABC/3TC/NVP (abacavir/lamivudine/nevirapine): First line regimen
|
NVP-sparing
n=5 Participants
Infants randomized to this arm will receive nevirapine-sparing HAART
AZT/3TC/ABC (zidovudine/lamivudine/abacavir): First line regimen
d4T/3TC/ABC (stavudine/lamivudine/abacavir): First line regimen For children who have anaemia(Hb of\<8g/dl), AZT will be substituted for d4T.
ddI/ABC/LPV/r (didanosine/abacavir/lopinavir-ritonavir): Second line regimen
ABC/ ddI or TDF / NVP or EFV (abacavir / didanosine or tenofovir / nevirapine or efavirenz): Second line regimen - Among children randomized to NVP sparing HAART, who will be initiated on a regimen containing lopinavir/ritonavir, zidovudine and lamivudine will be substituted with abacavir and didanosine or tenofovir (TDF) and lopinavir/ ritonavir will be replaced with nevirapine or efavirenz (EFV) in case of treatment failure of the LPV/r containing regimen.
|
|---|---|---|
|
Viral Failure
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: 15.6 person-years of follow-up overall at time of DSMB closure of study
Outcome measures
| Measure |
NVP-containing
n=17 Participants
Infants randomized to this arm will receive nevirapine-containing HAART regimen
AZT/3TC/NVP (zidovudine/lamivudine/nevirapine): First line regimen
d4T/3TC/NVP (stavudine/lamivudine/nevirapine): First line regimen
ABC/3TC/NVP (abacavir/lamivudine/nevirapine): First line regimen
|
NVP-sparing
n=17 Participants
Infants randomized to this arm will receive nevirapine-sparing HAART
AZT/3TC/ABC (zidovudine/lamivudine/abacavir): First line regimen
d4T/3TC/ABC (stavudine/lamivudine/abacavir): First line regimen For children who have anaemia(Hb of\<8g/dl), AZT will be substituted for d4T.
ddI/ABC/LPV/r (didanosine/abacavir/lopinavir-ritonavir): Second line regimen
ABC/ ddI or TDF / NVP or EFV (abacavir / didanosine or tenofovir / nevirapine or efavirenz): Second line regimen - Among children randomized to NVP sparing HAART, who will be initiated on a regimen containing lopinavir/ritonavir, zidovudine and lamivudine will be substituted with abacavir and didanosine or tenofovir (TDF) and lopinavir/ ritonavir will be replaced with nevirapine or efavirenz (EFV) in case of treatment failure of the LPV/r containing regimen.
|
|---|---|---|
|
Incidence of Severe Adverse Events (Excluding Mortality)
|
21 event
|
6 event
|
Adverse Events
NVP-containing
Serious events: 4 serious events
Other events: 13 other events
Deaths: 4 deaths
NVP-sparing
Serious events: 3 serious events
Other events: 15 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
NVP-containing
n=17 participants at risk
NVP-containing (AZT/3TC/NVP; d4T/3TC/NVP; or ABC/3TC/NVP) antiretroviral triple combination therapy.
Second-line regimens based on the WHO pediatric treatment guidelines, 2006.
|
NVP-sparing
n=17 participants at risk
NVP-sparing (AZT/3TC/LPV/r; or d4T/3TC/LPV/r1) antiretroviral triple combination therapy.
Second-line regimens based on the WHO pediatric treatment guidelines, 2006.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia or respiratory
|
23.5%
4/17 • 2 years
15.6 person years overall of follow-up at time of DSMB closure of study
|
5.9%
1/17 • 2 years
15.6 person years overall of follow-up at time of DSMB closure of study
|
|
Hepatobiliary disorders
Hepatotoxicity
|
11.8%
2/17 • 2 years
15.6 person years overall of follow-up at time of DSMB closure of study
|
5.9%
1/17 • 2 years
15.6 person years overall of follow-up at time of DSMB closure of study
|
|
Blood and lymphatic system disorders
Severe anemia
|
11.8%
2/17 • 2 years
15.6 person years overall of follow-up at time of DSMB closure of study
|
0.00%
0/17 • 2 years
15.6 person years overall of follow-up at time of DSMB closure of study
|
|
Gastrointestinal disorders
Hyperamylasemia
|
0.00%
0/17 • 2 years
15.6 person years overall of follow-up at time of DSMB closure of study
|
5.9%
1/17 • 2 years
15.6 person years overall of follow-up at time of DSMB closure of study
|
Other adverse events
| Measure |
NVP-containing
n=17 participants at risk
NVP-containing (AZT/3TC/NVP; d4T/3TC/NVP; or ABC/3TC/NVP) antiretroviral triple combination therapy.
Second-line regimens based on the WHO pediatric treatment guidelines, 2006.
|
NVP-sparing
n=17 participants at risk
NVP-sparing (AZT/3TC/LPV/r; or d4T/3TC/LPV/r1) antiretroviral triple combination therapy.
Second-line regimens based on the WHO pediatric treatment guidelines, 2006.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
17.6%
3/17 • 2 years
15.6 person years overall of follow-up at time of DSMB closure of study
|
41.2%
7/17 • 2 years
15.6 person years overall of follow-up at time of DSMB closure of study
|
|
Gastrointestinal disorders
Gastroenteritis
|
23.5%
4/17 • 2 years
15.6 person years overall of follow-up at time of DSMB closure of study
|
23.5%
4/17 • 2 years
15.6 person years overall of follow-up at time of DSMB closure of study
|
|
Nervous system disorders
Milestone regression
|
5.9%
1/17 • 2 years
15.6 person years overall of follow-up at time of DSMB closure of study
|
5.9%
1/17 • 2 years
15.6 person years overall of follow-up at time of DSMB closure of study
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
52.9%
9/17 • 2 years
15.6 person years overall of follow-up at time of DSMB closure of study
|
29.4%
5/17 • 2 years
15.6 person years overall of follow-up at time of DSMB closure of study
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place