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NCT00001649 · ClinicalTrials.gov registry record · Phase 3
Valaciclovir to Prevent Transmission of Herpes Simplex Virus
A Phase 3 study of Herpes Simplex, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 3
- Development phase
- 180
- Enrollment target
- 1
- Study location
NCT00001649: Completed Phase 3 study of Herpes Simplex, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00001649 is a Phase 3 study of Herpes Simplex that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 180 participants, below the 1,679-participant average among 4 other Herpes Simplex trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001649, a Phase 3 study of Herpes Simplex, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 180 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will evaluate the effectiveness of the drug valaciclovir in preventing transmission of genital herpes from an infected to an uninfected sexual partner. Genital herpes is caused by the herpes simplex virus 2 (HSV-2), or, infrequently herpes simplex virus 1 (HSV-1). Valaciclovir prevents the herpes virus from multiplying and may also reduce its transmission between partners. Couples 18 years of age and older in which one partner is infected with HSV-2 (source partner) and the other is not (susceptible partner), may be eligible for this study. Candidates will be screened with blood tests for routine laboratory studies and to verify the presence or absence of HSV-2 or HSV-1 infection. Participants will give a medical history, undergo a physical examination, including genital examination, and receive counseling on safer sex practices and how to recognize signs and symptoms of a possible first episode of genital herpes. Source partners will also be counseled on transmission of genital herpes, and susceptible partners will be interviewed about their sexual history and practices. The source partner will be randomly assigned to take either a 500-mg tablet of valaciclovir or placebo (a pill with no active ingredient) daily for 8 months. All participants will be given diary cards to complete for a month-the source partner will record any drug side effects and the susceptible partner will record any signs or symptoms of possible HSV infection. Participants will be seen in the clinic once a month for 8 months. At these visits, source partners will 1) return unused study medication and the completed diary card; 2) discuss any adverse drug side effects experienced in the last month; 3) review medications other than the study drug taken in the last month; 4) undergo counseling on safer sex practices, transmission of genital herpes, and recognizing signs and symptoms of a first episode of genital herpes; and 5) review symptoms and recurrences of genital herpes experien
Conditions Studied
Interventions
- DRUG Valaciclovir
Study Locations (1)
Maryland
- National Institute of Allergy and Infectious Diseases (NIAID) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 1997-08 |
| Est. Completion | 2003-08 |
| Phase | Phase 3 |
What the finished NCT00001649 record still lists
NCT00001649 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, below the 1,679-participant average among 4 other Herpes Simplex trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Herpes Simplex appearing as the primary indexed condition, and to 1 intervention - of which Valaciclovir is the first listed.
NCT00001649 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00001649 about?
NCT00001649 is a clinical study titled "Valaciclovir to Prevent Transmission of Herpes Simplex Virus". This study will evaluate the effectiveness of the drug valaciclovir in preventing transmission of genital herpes from an infected to an uninfected sexual partner. Genital herpes is caused by the herpes simplex virus 2 (HSV-2), or, infrequently herpes simplex virus 1 (HSV-1). Valaciclovir prevents th...
What is the current status of trial NCT00001649?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 180 participants. The study started on 1997-08. Estimated completion is 2003-08.
What conditions does trial NCT00001649 study?
This clinical trial studies the following conditions: Herpes Simplex.
What interventions are being tested in trial NCT00001649?
The interventions under investigation include: Valaciclovir (DRUG).
Who is sponsoring clinical trial NCT00001649?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001649 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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