Trial Outcomes & Findings for Valacyclovir vs. Acyclovir as HSV-2 Suppressive Therapy: Effect on Plasma HIV-1 Levels Among HIV-1/HSV-2 Co-infected Persons (NCT NCT01026454)

Last Updated: 2014-04-08

Results Overview

Mean level of HIV-1 RNA in plasma of participants while on 400 mg twice daily of acyclovir versus while on 1.5 g twice daily of valacyclovir.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

32 participants

Primary outcome timeframe

Weekly for 12 weeks per intervention

Results posted on

2014-04-08

Participant Flow

HSV-2/HIV-1 dually-infected participants were recruited between March and November 2010 from Thika, Kenya.

66 participants screened; 34 excluded (33 did not meet inclusion criteria, 1 declined study participation); 32 enrolled

Participant milestones

Participant milestones
Measure	Acyclovir Then Valacyclovir Acyclovir 400 mg orally twice daily (12 weeks), Washout (2 weeks), Valacyclovir 1.5 g orally twice daily (12 weeks)	Valacyclovir Then Acyclovir Valacyclovir 1.5 g orally twice daily (12 weeks), Washout (2 weeks), Acyclovir 400 mg orally twice daily (12 weeks)
First Intervention STARTED	18	14
First Intervention COMPLETED	18	14
First Intervention NOT COMPLETED	0	0
Washout STARTED	18	14
Washout COMPLETED	18	14
Washout NOT COMPLETED	0	0
Second Intervention STARTED	17	14
Second Intervention COMPLETED	16	13
Second Intervention NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Acyclovir Then Valacyclovir Acyclovir 400 mg orally twice daily (12 weeks), Washout (2 weeks), Valacyclovir 1.5 g orally twice daily (12 weeks)	Valacyclovir Then Acyclovir Valacyclovir 1.5 g orally twice daily (12 weeks), Washout (2 weeks), Acyclovir 400 mg orally twice daily (12 weeks)
Second Intervention Pregnancy	1	1

Baseline Characteristics

Valacyclovir vs. Acyclovir as HSV-2 Suppressive Therapy: Effect on Plasma HIV-1 Levels Among HIV-1/HSV-2 Co-infected Persons

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Acyclovir Then Valacyclovir n=18 Participants acyclovir 400 mg orally twice daily for 12 weeks, 2 week washout, then valacyclovir 1.5 g orally twice daily for 12 weeks	Valacyclovir Then Acyclovir n=14 Participants valacyclovir 1.5 g orally twice daily for 12 weeks, 2 week washout, then acyclovir 400 mg orally twice daily for 12 weeks	Total n=32 Participants Total of all reporting groups
Age, Customized <=18 years	0 participants n=93 Participants	0 participants n=4 Participants	0 participants n=27 Participants
Age, Customized Between 18 and 65 years	18 participants n=93 Participants	14 participants n=4 Participants	32 participants n=27 Participants
Age, Customized >=65 years	0 participants n=93 Participants	0 participants n=4 Participants	0 participants n=27 Participants
Sex: Female, Male Female	11 Participants n=93 Participants	7 Participants n=4 Participants	18 Participants n=27 Participants
Sex: Female, Male Male	7 Participants n=93 Participants	7 Participants n=4 Participants	14 Participants n=27 Participants
Region of Enrollment Kenya	18 participants n=93 Participants	14 participants n=4 Participants	32 participants n=27 Participants
Plasma HIV-1 RNA Level at Enrollment	4.05 log10 copies/mL STANDARD_DEVIATION 0.72 • n=93 Participants	4.08 log10 copies/mL STANDARD_DEVIATION 0.85 • n=4 Participants	4.07 log10 copies/mL STANDARD_DEVIATION 0.75 • n=27 Participants

PRIMARY outcome

Timeframe: Weekly for 12 weeks per intervention

Mean level of HIV-1 RNA in plasma of participants while on 400 mg twice daily of acyclovir versus while on 1.5 g twice daily of valacyclovir.

Outcome measures

Outcome measures
Measure	Acyclovir n=32 Participants acyclovir 400 mg twice daily 400 mg either in first intervention period or second	Valacyclovir n=31 Participants valacyclovir 1.5 g twice daily either in first intervention period or second
Mean Level of HIV-1 RNA in Plasma of Participants While on Acyclovir or Valacyclovir.	3.56 log10 copies/mL Interval 3.26 to 3.85	2.94 log10 copies/mL Interval 2.65 to 3.24

SECONDARY outcome

Timeframe: 28 weeks

Outcome measures

Outcome data not reported

Adverse Events

Acyclovir

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Valacyclovir

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Connie Celum, MD, MPH

University of Washington

Phone: 206-520-3800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place