Subjects will be recruited in three groups, all of whom are infected with HSV-1, as shown by having IgG against HSV-1:
Group A: 12 subjects with 6 or more herpes labialis outbreaks in the past 12 months.
Subjects in group A will receive 2% Squaric Acid Dibutyl Ester (SADBE) dose on the arm after their initial blood samples are obtained. Group A subjects will have blood collected and tests repeated 2 and 8 weeks later.
Subjects in Groups B and C will be matched to the subjects in Group A so that demographic characteristics (i.e., gender distribution, age and weight) are within broadly similar ranges.

Subjects will be recruited in three groups, all of whom are infected with HSV-1, as shown by having IgG against HSV-1:
Group B: 12 subjects with 1 to 2 outbreaks in the past 12 months. Subjects in Groups B and C will be matched to the subjects in Group A so that demographic characteristics (i.e., gender distribution, age and weight) are within broadly similar ranges. Invite these back for a further blood draw on Day 0.

Subjects will be recruited in three groups, all of whom are infected with HSV-1, as shown by having IgG against HSV-1:
Group C: 12 subjects with zero outbreaks in the past 12 months. Subjects in Groups B and C will be matched to the subjects in Group A so that demographic characteristics (i.e., gender distribution, age and weight) are within broadly similar ranges. Invite these back for a further blood draw on Day 0.

Herpes Labialis

2% squaric acid dibutyl ester (SADBE) (Supplied by Squarex) is topically applied to the inner aspect of the upper arm of the subject and covered with Tegaderm. Subject is advised to wash it off after 3 hours.

Squaric Acid Dibutyl Ester

Prism Clinical Research, LLC

Immune Response and General Immune Health in Subjects Infected With Herpes Simplex Virus Type 1 (HSV-1)

A Phase I Study of the Immune Response to Herpes Simplex Virus Type 1 (HSV-1) and General Immune Health in Subjects Infected With HSV-1

Cell Counts (Lymphocyte, T cell, B call, CD4, CD8, natural killer cells counts)

Serum Cytokine Levels ( IL2R, IL12, INFG, IL4, IL5, IL10, IL13, IL1B, IL6, IL8, TNFA, IL2, IL17) in pg/mL

RNA gene expression arrays for 42 cytokine and immune related genes, expressed as ratio of absolute gene expression in PBMCs for each group (A, B, C, those with 0, few, or 6 or more herpes labialis outbreaks in the prior 12 months) on Day 0,1 and 2 and a each test condition (no stimulus, HSV-1, HSV-infected cell extracts, or Candida).

PBMC proliferation in response to 3 stimuli: HSV-1 virus, HSV-1-infected cell extracts, and Candida albicans extract.

Squarex, LLC

Subjects will be recruited in three groups, all of whom are infected with HSV-1, as shown by having IgG against HSV-1:
x Group A: 12 subjects with 6 or more herpes labialis outbreaks in the past 12 months x Group B: 12 subjects with 1 to 2 outbreaks in the past 12 months x Group C: 12 subjects with zero outbreaks in the past 12 months Subjects in group A will receive 2% SADBE dose on the arm after their initial blood samples are obtained. Group A subjects will have blood collected and tests repeated 2 and 8 weeks later.
Subjects in Groups B and C will be matched to the subjects in Group A so that demographic characteristics (i.e., gender distribution, age and weight) are within broadly similar ranges.

Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0 and with 2% SADBE on the visits at week 3, week 6, week 9, and month 8.

Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0 and with 0.5% SADBE on the visits at week 3, week 6, week 9, and month 8.

Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0, month 3, and month 6.

Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0 and month 6.

Repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months).

International Research Partners, LLC

A Phase 2, Muti-Center Study of Repeat Dosing of Squaric Acid Dibutyl Ester in Subjects With Herpes Labialis

To assess local and generalized adverse events with repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months).

To assess efficacy of repeat topical application of 2% and 0.5% SADBE in the prevention of herpes labialis episodes.

Subjects will receive on a double blind basis one of two treatment regimens:
Group A: 15 subjects, treated with 2% SADBE on day 0 and with 2% SADBE on the visits at week 3, week 6, week 9, and month 8.
Group B: 15 subjects, treated with 2% SADBE on day 0 and with 0.5% SADBE on the visits at week 3, week 6, week 9, and month 8.
And subjects will be recruited on an open label basis to two other treatment regimens:
Group C: 15 subjects, treated with 2% SADBE on day 0, month 3, and month 6.
Group D: 15 subjects, treated with 2% SADBE on day 0 and month 6.

The double-blinding only applies between groups A and B. Subjects for groups C and D will be recruited on an open label basis.

Valacyclovir 500 mg po bid
Valacyclovir: Valacyclovir 500 mg po bid

Valacyclovir

Matching placebo twice daily
Placebo: Placebo tablet twice daily

Placebo

Total

Sex: Female, Male

Region of Enrollment

Measure change in HCV RNA viral load in treatment group as compared with placebo

Change in HCV RNA Viral Load

Overall Study

Mary Jane Burton

Chronic Hepatitis C Infection

G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS

Herpes Simplex Type 1 Suppression in Hepatitis C

HSV-1 Suppression in HCV Infected Veterans Who Are Seronegative for HSV-2

VA Office of Research and Development

GlaxoSmithKline

Valacyclovir: 500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks

Placebo: Dosage: Two tablets once a day for 24 weeks

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Absolute CD4 (cluster of differentiation 4) Count

Number with Undetectable Viral Load

Herpes Simplex Virus Type 2 Recurrence

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

CD4 Count

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

Number of Participants With an HIV Viral Load of <500 Copies/ml

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.

Rate of Asymptomatic HSV-2 Genital Shedding

Nicholas Van Wagoner

HIV Infections

500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks

Dosage: Two tablets once a day for 24 weeks

herpes labialis/fever

Immune Response and General Immune Health in Subjects Infected With Herpes Simplex Virus Type 1 (HSV-1)

A Phase 2, Muti-Center Study of Repeat Dosing of Squaric Acid Dibutyl Ester in Subjects With Herpes Labialis

Herpes Simplex Type 1 Suppression in Hepatitis C

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

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