Trial Outcomes & Findings for HSV-2 Suppression to Reduce Maternal HIV-1 RNA Levels During Pregnancy and Breastfeeding (NCT NCT00530777)

NCT ID: NCT00530777

Last Updated: 2018-12-19

Results Overview

Calculated as log10 plasma viral load at 34 weeks gestation - log10 plasma viral load at 38 weeks gestation

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 148 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2018-12-19

Participant Flow

HIV-1 infected pregnant women seeking antenatal care at the Mathare North City Council Clinic in Nairobi Kenya, or referred from neighboring clinics, were recruited for study screening

Participant milestones

Measure	Valacyclovir 500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum	Placebo oral placebo twice daily from 34 weeks gestation to 1 year postpartum
Overall Study STARTED	74	74
Overall Study COMPLETED	67	69
Overall Study NOT COMPLETED	7	5

Reasons for withdrawal

Measure	Valacyclovir 500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum	Placebo oral placebo twice daily from 34 weeks gestation to 1 year postpartum
Overall Study Lost to Follow-up	0	1
Overall Study Death	1	2
Overall Study Physician Decision	1	0
Overall Study Withdrawal by Subject	0	1
Overall Study Unable to adhere to visit schedule	5	1

Baseline Characteristics

HSV-2 Suppression to Reduce Maternal HIV-1 RNA Levels During Pregnancy and Breastfeeding

Baseline characteristics by cohort

Measure	Valacyclovir n=74 Participants 500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum	Placebo n=74 Participants oral placebo twice daily from 34 weeks gestation to 1 year postpartum	Total n=148 Participants Total of all reporting groups
Age, Categorical <=18 years	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	71 Participants n=5 Participants	70 Participants n=7 Participants	141 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	26.2 years STANDARD_DEVIATION 5.3 • n=5 Participants	26.0 years STANDARD_DEVIATION 4.5 • n=7 Participants	26.1 years STANDARD_DEVIATION 4.9 • n=5 Participants
Sex: Female, Male Female	74 Participants n=5 Participants	74 Participants n=7 Participants	148 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	74 participants n=5 Participants	74 participants n=7 Participants	148 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: Women with paired plasma samples at 34 and 38 weeks gestation

Calculated as log10 plasma viral load at 34 weeks gestation - log10 plasma viral load at 38 weeks gestation

Outcome measures

Measure	Valacyclovir n=51 Participants 500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum	Placebo n=49 Participants oral placebo twice daily from 34 weeks gestation to 1 year postpartum
Mean Change in HIV-1 Levels in Plasma Between 34 and 38 Weeks Gestation	-0.53 log10 copies/mL Standard Deviation .074	0.03 log10 copies/mL Standard Deviation 0.76

SECONDARY outcome

Timeframe: 1 year postpartum

Population: Note the sample size is 73 for each group rather than 74 due to loss to follow-up.

Mother-to-child HIV transmission

Outcome measures

Measure	Valacyclovir n=73 Participants 500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum	Placebo n=73 Participants oral placebo twice daily from 34 weeks gestation to 1 year postpartum
Vertical HIV-1 Transmission	6 Participants	4 Participants

Adverse Events

Valacyclovir

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Valacyclovir n=74 participants at risk 500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum	Placebo n=74 participants at risk oral placebo twice daily from 34 weeks gestation to 1 year postpartum
Investigations Death	100.0% 1/1 • Number of events 1	100.0% 2/2 • Number of events 2

Other adverse events

Adverse event data not reported

Additional Information

Dr. Carey Farquhar

University of Washington

Phone: 206-543-4278

Email: cfarq@uw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place