Trial Outcomes & Findings for ARVs to Prevent Breastmilk HIV:Viral and Immune Responses (NCT NCT00167674)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

58 participants

Primary outcome timeframe

Weeks 0, 1, 2, 3 and 4

Results posted on

2025-01-15

Enrollment between Nov 3, 2003 and Mar 11, 2005 Mathare North City Council Clinic

Participant milestones
Measure	ZDV/NVP Combined short-course Zidovudine/Nevirapine Combined short-course zidovudine/nevirapine: 300 mg of ZDV was given twice daily from 34 weeks gestation until labor then every 3 hours until delivery; 200 mg of NVP was given as a single oral dose at the onset of labor; and a single 2 mg/kg (6 mg if birthweight \> 2.5 kg) oral dose of NVP suspension was administered to the infant within 72 hours of delivery.	HAART HAART during pregnancy and 6 months postpartum HAART: 300 mg of zidovudine (ZDV), 150 mg of lamivudine, and 200 mg nevirapine (NVP) was given twice daily from 34 weeks gestation until six months after delivery.
Overall Study STARTED	28	30
Overall Study COMPLETED	24	24
Overall Study NOT COMPLETED	4	6

Withdrawal data not reported

ARVs to Prevent Breastmilk HIV:Viral and Immune Responses

Baseline characteristics by cohort
Measure	ZDV/NVP n=28 Participants Combined short-course Zidovudine/Nevirapine Combined short-course zidovudine/nevirapine: 300 mg of ZDV was given twice daily from 34 weeks gestation until labor then every 3 hours until delivery; 200 mg of NVP was given as a single oral dose at the onset of labor; and a single 2 mg/kg (6 mg if birthweight \> 2.5 kg) oral dose of NVP suspension was administered to the infant within 72 hours of delivery.	HAART n=30 Participants HAART during pregnancy and 6 months postpartum HAART: 300 mg of zidovudine (ZDV), 150 mg of lamivudine, and 200 mg nevirapine (NVP) was given twice daily from 34 weeks gestation until six months after delivery.	Total n=58 Participants Total of all reporting groups
Age, Continuous	24 years n=5 Participants	26 years n=7 Participants	25 years n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	30 Participants n=7 Participants	58 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Kenya	28 participants n=5 Participants	30 participants n=7 Participants	58 participants n=5 Participants
Region of Enrollment Africa	28 participants n=5 Participants	30 participants n=7 Participants	58 participants n=5 Participants

Timeframe: Weeks 0, 1, 2, 3 and 4

Population: Participants with VL data available.

Outcome measures
Measure	ZDV/NVP n=24 Participants Combined short-course Zidovudine/Nevirapine Combined short-course zidovudine/nevirapine: 300 mg of ZDV was given twice daily from 34 weeks gestation until labor then every 3 hours until delivery; 200 mg of NVP was given as a single oral dose at the onset of labor; and a single 2 mg/kg (6 mg if birthweight \> 2.5 kg) oral dose of NVP suspension was administered to the infant within 72 hours of delivery.	HAART n=26 Participants HAART during pregnancy and 6 months postpartum HAART: 300 mg of zidovudine (ZDV), 150 mg of lamivudine, and 200 mg nevirapine (NVP) was given twice daily from 34 weeks gestation until six months after delivery.
Outcome 1: Serial HIV-1 RNA Levels in Breastmilk. Week 0	2.74 Log10 Viral load copies/ml Interval 2.23 to 3.43	2.03 Log10 Viral load copies/ml Interval 1.7 to 2.41
Outcome 1: Serial HIV-1 RNA Levels in Breastmilk. Week 1	1.70 Log10 Viral load copies/ml Interval 1.7 to 2.35	1.70 Log10 Viral load copies/ml Interval 1.7 to 1.73
Outcome 1: Serial HIV-1 RNA Levels in Breastmilk. Week 2	1.70 Log10 Viral load copies/ml Interval 1.7 to 2.14	1.70 Log10 Viral load copies/ml Interval 1.7 to 1.7
Outcome 1: Serial HIV-1 RNA Levels in Breastmilk. Week 3	2.22 Log10 Viral load copies/ml Interval 1.91 to 3.12	1.70 Log10 Viral load copies/ml Interval 1.7 to 1.7
Outcome 1: Serial HIV-1 RNA Levels in Breastmilk. Week 4	2.11 Log10 Viral load copies/ml Interval 1.7 to 3.07	1.70 Log10 Viral load copies/ml Interval 1.7 to 1.7

Serious events: 3 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events
Measure	ZDV/NVP n=24 participants at risk Combined short-course Zidovudine/Nevirapine Combined short-course zidovudine/nevirapine: 300 mg of ZDV was given twice daily from 34 weeks gestation until labor then every 3 hours until delivery; 200 mg of NVP was given as a single oral dose at the onset of labor; and a single 2 mg/kg (6 mg if birthweight \> 2.5 kg) oral dose of NVP suspension was administered to the infant within 72 hours of delivery.	HAART n=26 participants at risk HAART during pregnancy and 6 months postpartum HAART: 300 mg of zidovudine (ZDV), 150 mg of lamivudine, and 200 mg nevirapine (NVP) was given twice daily from 34 weeks gestation until six months after delivery.
Infections and infestations Death	12.5% 3/24 • Number of events 3	0.00% 0/26

Adverse event data not reported

University of Washington

Phone: 206 948 9357