Trial Outcomes & Findings for Effect of Valacyclovir in the Reduction of HSV-2 Recurrence and Shedding (NCT NCT00803543)

NCT ID: NCT00803543

Last Updated: 2017-07-13

Results Overview

Number of recurrences of genital herpes

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 103 participants
• Primary outcome timeframe: 24 Weeks
• Results posted on: 2017-07-13

Participant Flow

Participant milestones

Measure	Valacyclovir Valacyclovir: 500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks	Placebo Placebo: Dosage: Two tablets once a day for 24 weeks
Overall Study STARTED	69	34
Overall Study COMPLETED	45	22
Overall Study NOT COMPLETED	24	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Valacyclovir in the Reduction of HSV-2 Recurrence and Shedding

Baseline characteristics by cohort

Measure	Valacyclovir n=45 Participants Valacyclovir: 500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks	Placebo n=22 Participants Placebo: Dosage: Two tablets once a day for 24 weeks	Total n=67 Participants Total of all reporting groups
Age, Continuous	45 years n=5 Participants	43 years n=7 Participants	45 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	1 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	21 Participants n=7 Participants	58 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	45 Participants n=5 Participants	22 Participants n=7 Participants	67 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	25 Participants n=5 Participants	9 Participants n=7 Participants	34 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants	13 Participants n=7 Participants	33 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	45 participants n=5 Participants	22 participants n=7 Participants	67 participants n=5 Participants
Absolute CD4 (cluster of differentiation 4) Count	528 cell/ml n=5 Participants	693 cell/ml n=7 Participants	582 cell/ml n=5 Participants
Number with Undetectable Viral Load	40 participants n=5 Participants	19 participants n=7 Participants	59 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 Weeks

Population: No participants reported genital herpes recurrence during the study.

Number of recurrences of genital herpes

Outcome measures

Measure	Valacyclovir n=45 Participants Valacyclovir: 500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks	Placebo n=22 Participants Placebo: Dosage: Two tablets once a day for 24 weeks
Herpes Simplex Virus Type 2 Recurrence	0 Recurrence	0 Recurrence

PRIMARY outcome

Timeframe: 24 weeks

CD4 count as measured after 24 weeks of placebo versus valacyclovir. Reports as cells/ml

Outcome measures

Measure	Valacyclovir n=45 Participants Valacyclovir: 500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks	Placebo n=22 Participants Placebo: Dosage: Two tablets once a day for 24 weeks
CD4 Count	536 cells/ml Interval 191.0 to 1112.0	627.5 cells/ml Interval 199.0 to 1268.0

PRIMARY outcome

Timeframe: 24 weeks

Number of participants with an HIV Viral Load of <500 copies/ml at 24 weeks

Outcome measures

Measure	Valacyclovir n=45 Participants Valacyclovir: 500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks	Placebo n=22 Participants Placebo: Dosage: Two tablets once a day for 24 weeks
Number of Participants With an HIV Viral Load of <500 Copies/ml	38 Participants	20 Participants

PRIMARY outcome

Timeframe: 24 weeks

Proportion of days on which HSV shedding was observed. This part of the study was performed in a subset of participants (N = 34). Participant collected daily genital specimens for 8 weeks starting at week 16 and continuing through week 24 of the study.

Outcome measures

Measure	Valacyclovir n=1456 Total Number of Days Assessed Valacyclovir: 500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks	Placebo n=448 Total Number of Days Assessed Placebo: Dosage: Two tablets once a day for 24 weeks
Rate of Asymptomatic HSV-2 Genital Shedding	0.0009 Proportion of days	0.0001 Proportion of days

Adverse Events

Valacyclovir

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Nicholas Van Wagoner

University of Alabama at Birmingham

Phone: 205-934-2840

Email: nvw@uab.edu

Results disclosure agreements

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