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NCT00527618 · ClinicalTrials.gov registry record · Phase 4
Trial to Study the Effect of Dose of Herpes Simplex Virus-2 (HSV-2) Suppressive Therapy on HSV and HIV
A Phase 4 study, sponsored by University of Washington.
- Completed
- Registry status
- Phase 4
- Development phase
- 28
- Enrollment target
NCT00527618: Completed Phase 4 study, sponsored by University of Washington.
NCT00527618 is a Phase 4 study that has completed, run by University of Washington. The registered enrollment target is 28 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00527618, a Phase 4 study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 28 participants
- Enrollment target
Study Summary
To compare the effect of high-dose valacyclovir (1 gram orally twice daily) versus standard-dose acyclovir (400 mg orally twice daily) on the frequency of genital HSV reactivation and on plasma HIV-1 levels among HSV-2/HIV-1 co-infected individuals. The investigators hypothesize that high-dose valacyclovir will result in greater reduction in plasma HIV-1 and genital HSV reactivation.
Primary Outcome
Weekly measurements of plasma HIV-1 RNA on each drug were compared. The primary analysis was of the average difference in plasma HIV-1 RNA on valacyclovir and acyclovir as determined by a linear mixed model. The median of the average per-participant plasma HIV-1 RNA levels on valacyclovir and valacyclovir is also listed.
Interventions
- DRUG valacyclovir
- DRUG acyclovir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2007-12 |
| Est. Completion | 2011-03 |
| Phase | Phase 4 |
What the finished NCT00527618 record still lists
NCT00527618 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which valacyclovir is the first listed.
NCT00527618 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00527618 about?
NCT00527618 is a clinical study titled "Trial to Study the Effect of Dose of Herpes Simplex Virus-2 (HSV-2) Suppressive Therapy on HSV and HIV". To compare the effect of high-dose valacyclovir (1 gram orally twice daily) versus standard-dose acyclovir (400 mg orally twice daily) on the frequency of genital HSV reactivation and on plasma HIV-1 levels among HSV-2/HIV-1 co-infected individuals. The investigators hypothesize that high-dose valac...
What is the current status of trial NCT00527618?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 28 participants. The study started on 2007-12. Estimated completion is 2011-03.
What interventions are being tested in trial NCT00527618?
The interventions under investigation include: valacyclovir (DRUG), acyclovir (DRUG).
Who is sponsoring clinical trial NCT00527618?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00527618's enrollment target sits among peer trials
28 1635th of 2000 higher than 350 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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