Trial · NCT00477334
Patient-initiated Episodic Treatment of Recurrent Genital Herpes in Black Patients
NCT00477334, Phase 4, Completed, Novartis; results first posted 2011-03-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Patient-initiated Episodic Treatment of Recurrent Genital Herpes in Black Patients. Trials, record NCT00477334. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00477334
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Patient-initiated Episodic Treatment of Recurrent Genital Herpes in Black Patients
- NCT number
- NCT00477334
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 463 participants, actual
- Lead sponsor
- Novartis
- Conditions
- Genital Herpes
- Interventions
- Famciclovir, Placebo
- First posted
- 2007-05-23
- Last updated
- 2011-03-28
- Results first posted
- 2011-03-16
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Investigator Assessed Time to Healing of All Non-aborted Genital Herpes Lesions | 21 days | Time to healing of all non-aborted genital herpes lesions, defined as the time from the first dose of study medication to the investigator-assessed time of healing (i.e. loss of all crusts and re-epithelialization of lesions; erythema may be present). |
| Secondary | Percentage of Participants With Aborted and Non-aborted Genital Herpes Lesions During the Treatment Period | 21 days | |
| Secondary | Investigator Assessed Time to Healing of All Non-aborted and Aborted Genital Herpes Lesions | 21 days | Kaplan-Meier estimation. |
| Secondary | Time to Resolution of Symptoms Associated With Recurrent Genital Herpes | 72 hour after initiation of study medication up to 21 days | Median time to resolution of symptoms: all symptoms, pain, burning, itching, tingling and tenderness associated with recurrent genital herpes estimated using Kaplan-Meier method. |
| Secondary | Number of Participants With a Second Recurrence of Genital Herpes in the Follow-up Period | 6 months | Number of participants with a second recurrence of genital herpes in the follow-up period. |
| Secondary | Time to Second Recurrence of Genital Herpes | 6 months | Kaplan Meier estimated time in days to second recurrent from treatment initiation and from the date of healing of aborted lesions. |
| Secondary | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment | Baseline, Day 2 | The number of participants with clinically noted shifts in Hematology tests from normal at baseline are graded based on Division of Microbiology and Infectious Diseases (DMID) toxicity tables from Grade 1 toxicity (smallest change) to Grade 4 toxicity (largest change). Grade 3 and 4 toxicities are considered to be clinically meaningful. |
| Secondary | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | Baseline, Day 2 | The number of participants with clinically noted shifts in Clinical Chemistry tests from normal at baseline are graded based on Division of Microbiology and Infectious Diseases (DMID) toxicity tables from Grade 1 toxicity (smallest change) to Grade 4 toxicity (largest change). Grade 3 and 4 toxicities are considered to be clinically meaningful. SGPT(ALT)= Serum Glutamic Pyruvate Transaminase (Alanine Aminotransferase) and SGOT(AST)= Serum Glutamic Oxalacetic Transaminase (Aspartate Aminotransferase) |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Investigator Assessed Time to Healing of All Non-aborted Genital Herpes Lesions | 21 days | Modified Intent to Treat Population (mITT) that includes all Intent to Treat participants with non-aborted genital herpes lesions during the treatment period. | Days | MEDIAN |
| SECONDARY | Percentage of Participants With Aborted and Non-aborted Genital Herpes Lesions During the Treatment Period | 21 days | Intent-to-Treat (ITT). All randomized participants who initiated treatment (i.e. received any dose of the study drug) with the intention of treating genital herpes recurrences. | Percentage of Participants | NUMBER |
| SECONDARY | Investigator Assessed Time to Healing of All Non-aborted and Aborted Genital Herpes Lesions | 21 days | ITT participants who discontinued from the study before healing of non aborted lesions was confirmed and participants who completed the study after 21 days since treatment initiation without non aborted lesion stages and without a final assessment on aborted lesion status were assumed as having non aborted lesions in this analysis. | Days | MEDIAN |
| SECONDARY | Time to Resolution of Symptoms Associated With Recurrent Genital Herpes | 72 hour after initiation of study medication up to 21 days | Intent to Treat Population. If a participant never had a symptom prior to the last valid diary entry for the first recurrence, then the time to resolution of the symptom was set to missing and the participant was not included in the analysis. | Days | MEDIAN |
| SECONDARY | Number of Participants With a Second Recurrence of Genital Herpes in the Follow-up Period | 6 months | Intent to Treat Population: participants who completed the first recurrence. | Participants | NUMBER |
| SECONDARY | Time to Second Recurrence of Genital Herpes | 6 months | Intent to Treat Population: participants who completed the first recurrence. | Days | MEDIAN |
| SECONDARY | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment | Baseline, Day 2 | 304 Participants = 206 participants in the Famciclovir Group + 98 participants in the Placebo Group. Individual n values in each of the categories is the number of participants in the group with normal baseline values and at least one non-missing post baseline measurement. | Participants | NUMBER |
| SECONDARY | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | Baseline, Day 2 | 304 Participants = 206 participants in the Famciclovir Group + 98 participants in the Placebo Group. Individual n values in each of the categories is the number of participants in the group with normal baseline values and at least one non-missing post baseline measurement. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group122
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Investigator Assessed Time to Healing of All Non-aborted Genital Herpes Lesions | Famciclovir 1000 mg | 5.38 | Inter-Quartile Range 3.82 to 7.35 | Days | |
| Investigator Assessed Time to Healing of All Non-aborted Genital Herpes Lesions | Placebo Comparator | 4.79 | Inter-Quartile Range 3.56 to 7.03 | Days | |
| Percentage of Participants With Aborted and Non-aborted Genital Herpes Lesions During the Treatment Period | Famciclovir 1000 mg | Percentage with aborted lesions (n=49,20) | 24.4 | Percentage of Participants | |
| Percentage of Participants With Aborted and Non-aborted Genital Herpes Lesions During the Treatment Period | Placebo Comparator | Percentage with aborted lesions (n=49,20) | 20.4 | Percentage of Participants | |
| Percentage of Participants With Aborted and Non-aborted Genital Herpes Lesions During the Treatment Period | Famciclovir 1000 mg | Percentage with non-aborted lesions (n= 152,78) | 75.6 | Percentage of Participants | |
| Percentage of Participants With Aborted and Non-aborted Genital Herpes Lesions During the Treatment Period | Placebo Comparator | Percentage with non-aborted lesions (n= 152,78) | 79.6 | Percentage of Participants | |
| Investigator Assessed Time to Healing of All Non-aborted and Aborted Genital Herpes Lesions | Famciclovir 1000 mg | 4.13 | Inter-Quartile Range 1.24 to 6.00 | Days | |
| Investigator Assessed Time to Healing of All Non-aborted and Aborted Genital Herpes Lesions | Placebo Comparator | 4.06 | Inter-Quartile Range 2.01 to 6.64 | Days | |
| Time to Resolution of Symptoms Associated With Recurrent Genital Herpes | Famciclovir 1000 mg | All symptoms (n=195/98) | 4.5 | Inter-Quartile Range 2.8 to 8.2 | Days |
| Time to Resolution of Symptoms Associated With Recurrent Genital Herpes | Placebo Comparator | All symptoms (n=195/98) | 5.7 | Inter-Quartile Range 2.8 to 9.0 | Days |
1 to 10 of 122Source ClinicalTrials.gov
See all 122 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Famciclovir 1000 mg | 312 | |
| Overall Study | STARTED | Placebo Comparator | 151 | |
| Overall Study | Randomized and Took Study Drug | Famciclovir 1000 mg | 206 | |
| Overall Study | Randomized and Took Study Drug | Placebo Comparator | 98 | |
| Overall Study | Intent to Treat Population | Famciclovir 1000 mg | 201 | |
| Overall Study | Intent to Treat Population | Placebo Comparator | 98 | |
| Overall Study | Participants Completing First Recurrence | Famciclovir 1000 mg | 187 | |
| Overall Study | Participants Completing First Recurrence | Placebo Comparator | 92 | |
| Overall Study | Modified Intent to Treat Population | Famciclovir 1000 mg | 152 | |
| Overall Study | Modified Intent to Treat Population | Placebo Comparator | 78 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events30
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | Famciclovir 1000 mg | 10 | 206 | |
| other | Headache | Nervous system disorders | Placebo Comparator | 2 | 98 | |
| other | Nausea | Gastrointestinal disorders | Famciclovir 1000 mg | 5 | 206 | |
| other | Nausea | Gastrointestinal disorders | Placebo Comparator | 2 | 98 | |
| other | Diarrhoea | Gastrointestinal disorders | Famciclovir 1000 mg | 3 | 206 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo Comparator | 1 | 98 | |
| other | Blood Pressure increased | Investigations | Famciclovir 1000 mg | 2 | 206 | |
| other | Blood Pressure increased | Investigations | Placebo Comparator | 0 | 98 | |
| other | Decreased appetite | Metabolism and nutrition disorders | Famciclovir 1000 mg | 2 | 206 | |
| other | Decreased appetite | Metabolism and nutrition disorders | Placebo Comparator | 0 | 98 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Famciclovir 1000 mg | ||
| Total, all-cause mortality | Placebo Comparator | ||
| Total, other adverse events | Famciclovir 1000 mg | 26 | 206 |
| Total, other adverse events | Placebo Comparator | 11 | 98 |
| Total, serious adverse events | Famciclovir 1000 mg | 2 | 206 |
| Total, serious adverse events | Placebo Comparator | 1 | 98 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20070143 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Famciclovir 1000 mg vs Placebo Comparator: Number of Participants With a Second Recurrence of Genital Herpes in the Follow-up Period | Trial comparisons |
| Famciclovir 1000 mg vs Placebo Comparator: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00477334
GET https://conductscience.org/api/trials/v1/NCT00477334/results?page=2