Trial Outcomes & Findings for Antiretroviral Regimens Containing Raltegravir for Prophylaxis of Mother-to-child-transmission of HIV Infection (NCT NCT01854762)
NCT ID: NCT01854762
Last Updated: 2024-10-15
Results Overview
Number of participants presenting with PVL\<50 copies/mL at delivery
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
33 participants
Primary outcome timeframe
2, 4, 6 weeks and at delivery
Results posted on
2024-10-15
Participant Flow
Participant milestones
| Measure |
Raltegravir
Patients in raltegravir group received the standard dose of one 400 mg tablet twice a day, in combination with zidovudine 300 mg plus lamivudine 150 mg, in a co-formulated pill, twice a day.
|
Lopinavir/Ritonavir
Participants in lopinavir/ritonavir group received two tablets containing lopinavir 200 mg plus ritonavir 100 mg twice a day, plus one zidovudine 300 mg plus lamivudine 150 mg co-formulated pill, twice a day.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
16
|
|
Overall Study
COMPLETED
|
17
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Antiretroviral Regimens Containing Raltegravir for Prophylaxis of Mother-to-child-transmission of HIV Infection
Baseline characteristics by cohort
| Measure |
Raltegravir
n=17 Participants
Use of Raltegravir plus backbone treatment for pregnant women
Raltegravir: a raltegravir-based antiretroviral regimen (AZT+3TC+Raltegravir) will be administered for intervention arm patients (AZT+3TC will be administered in a fixed combination of AZT 300mg +3TC 150 mg, BID. Raltegravir will be administered in a dosis of 1 400 mg pill BID).
|
Lopinavir/Ritonavir
n=16 Participants
Use of standard PI treatment (Lopinavir/r) plus backbone treatment for pregnant women
Lopinavir/Ritonavir: The second arm (comparator)patients will use a regimen composed by AZT+3TC (same dosis/schedule of active arm)+ LPV 200mg combined with rtv 50 mg, 2 pills BID
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.7 years
n=5 Participants
|
26.7 years
n=7 Participants
|
26.7 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
white
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/mixed
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
17 participants
n=5 Participants
|
16 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Mean Plasma HIV-1 Viral load
|
12859 copies/mL
n=5 Participants
|
21143 copies/mL
n=7 Participants
|
15309 copies/mL
n=5 Participants
|
|
Mean CD4 count
|
497 cells/mL
n=5 Participants
|
532 cells/mL
n=7 Participants
|
509 cells/mL
n=5 Participants
|
|
Mean haemoglobin
|
10.7 g/dL
n=5 Participants
|
10.7 g/dL
n=7 Participants
|
10.7 g/dL
n=5 Participants
|
|
Gestational age
|
32.7 weeks
n=5 Participants
|
32.5 weeks
n=7 Participants
|
32.5 weeks
n=5 Participants
|
PRIMARY outcome
Timeframe: 2, 4, 6 weeks and at deliveryPopulation: Frequency of PVL\<50 copies/mL at delivery
Number of participants presenting with PVL\<50 copies/mL at delivery
Outcome measures
| Measure |
Raltegravir
n=17 Participants
Patients in raltegravir group received the standard dose of one 400 mg tablet twice a day, in combination with zidovudine 300 mg plus lamivudine 150 mg, in a co-formulated pill, twice a day.
|
Lopinavir/Ritonavir
n=16 Participants
Participants in lopinavir/ritonavir group received two tablets containing lopinavir 200 mg plus ritonavir 100 mg twice a day, plus one zidovudine 300 mg plus lamivudine 150 mg co-formulated pill, twice a day.
|
|---|---|---|
|
HIV Viral Load at Delivery
Frequency of VL<50 at delivery
|
13 Participants
|
4 Participants
|
|
HIV Viral Load at Delivery
Frequency of VL<50 at 2 weeks
|
7 Participants
|
1 Participants
|
|
HIV Viral Load at Delivery
Frequency of VL<50 at 4 weeks
|
9 Participants
|
2 Participants
|
|
HIV Viral Load at Delivery
Frequency of VL<50 at 6 weeks
|
10 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 2, 4, 6 weeks and at deliveryPopulation: Overall frequency od Adverse events
Frequency of clinical and laboratory abnormalities by arm
Outcome measures
| Measure |
Raltegravir
n=17 Participants
Patients in raltegravir group received the standard dose of one 400 mg tablet twice a day, in combination with zidovudine 300 mg plus lamivudine 150 mg, in a co-formulated pill, twice a day.
|
Lopinavir/Ritonavir
n=16 Participants
Participants in lopinavir/ritonavir group received two tablets containing lopinavir 200 mg plus ritonavir 100 mg twice a day, plus one zidovudine 300 mg plus lamivudine 150 mg co-formulated pill, twice a day.
|
|---|---|---|
|
Overall Adverse Events up to Delivery
|
4 adverse events
|
10 adverse events
|
SECONDARY outcome
Timeframe: 4 weeks after deliveryDetectable plasma HIV-1 RNA viral load at 4 weeks after delivery
Outcome measures
| Measure |
Raltegravir
n=17 Participants
Patients in raltegravir group received the standard dose of one 400 mg tablet twice a day, in combination with zidovudine 300 mg plus lamivudine 150 mg, in a co-formulated pill, twice a day.
|
Lopinavir/Ritonavir
n=16 Participants
Participants in lopinavir/ritonavir group received two tablets containing lopinavir 200 mg plus ritonavir 100 mg twice a day, plus one zidovudine 300 mg plus lamivudine 150 mg co-formulated pill, twice a day.
|
|---|---|---|
|
Number of Children Infected With HIV
|
0 Participants
|
0 Participants
|
Adverse Events
Raltegravir
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Lopinavir/Ritonavir
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Raltegravir
n=17 participants at risk
Patients in raltegravir group received the standard dose of one 400 mg tablet twice a day, in combination with zidovudine 300 mg plus lamivudine 150 mg, in a co-formulated pill, twice a day.
|
Lopinavir/Ritonavir
n=16 participants at risk
Participants in lopinavir/ritonavir group received two tablets containing lopinavir 200 mg plus ritonavir 100 mg twice a day, plus one zidovudine 300 mg plus lamivudine 150 mg co-formulated pill, twice a day.
|
|---|---|---|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/17 • AE data were collected from baseline to delivery time (up to 8 weeks)
clinical AE and laboratory AE were assessed at 2, 4 and 6 weeks and at delivery. The total number of adverse events leadinbg up to delivery, are reported
|
31.2%
5/16 • Number of events 5 • AE data were collected from baseline to delivery time (up to 8 weeks)
clinical AE and laboratory AE were assessed at 2, 4 and 6 weeks and at delivery. The total number of adverse events leadinbg up to delivery, are reported
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/17 • AE data were collected from baseline to delivery time (up to 8 weeks)
clinical AE and laboratory AE were assessed at 2, 4 and 6 weeks and at delivery. The total number of adverse events leadinbg up to delivery, are reported
|
31.2%
5/16 • Number of events 5 • AE data were collected from baseline to delivery time (up to 8 weeks)
clinical AE and laboratory AE were assessed at 2, 4 and 6 weeks and at delivery. The total number of adverse events leadinbg up to delivery, are reported
|
|
General disorders
headache
|
0.00%
0/17 • AE data were collected from baseline to delivery time (up to 8 weeks)
clinical AE and laboratory AE were assessed at 2, 4 and 6 weeks and at delivery. The total number of adverse events leadinbg up to delivery, are reported
|
18.8%
3/16 • Number of events 3 • AE data were collected from baseline to delivery time (up to 8 weeks)
clinical AE and laboratory AE were assessed at 2, 4 and 6 weeks and at delivery. The total number of adverse events leadinbg up to delivery, are reported
|
|
General disorders
miscelaneous
|
23.5%
4/17 • Number of events 4 • AE data were collected from baseline to delivery time (up to 8 weeks)
clinical AE and laboratory AE were assessed at 2, 4 and 6 weeks and at delivery. The total number of adverse events leadinbg up to delivery, are reported
|
62.5%
10/16 • Number of events 13 • AE data were collected from baseline to delivery time (up to 8 weeks)
clinical AE and laboratory AE were assessed at 2, 4 and 6 weeks and at delivery. The total number of adverse events leadinbg up to delivery, are reported
|
Additional Information
Dr. Carlos Brites
Fundação Bahiana de Infectologia / Universidade Federal da Bahia
Phone: 5571992329552
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place