Phase 4
Completed N=48
A Randomized Trial to Evaluated the Suppressive Effect of Acyclovir on Rapidly Cleared HSV-2 Reactivation
Source: ClinicalTrials.gov NCT00723229 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: Frequency of HSV-2 Total Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per-day Shedding Rate in Participants Treated With Suppressive Acyclovir as Compared to no Medication in HIV Seronegative and HIV Seropositive Individuals. — 24; 3; 15; 7 percentage of swabs with HSV detected — p=<0.001
◆ Published Evidence
Highly cited
123citations · ~9 / year
Standard-dose and high-dose daily antiviral therapy for short episodes of genital HSV-2 reactivation: three randomised, open-label, cross-over trials.
Summary
We propose to study the episode rate, duration, and quantity of HSV-2 genital shedding in patients taking standard, FDA approved, CDC recommended doses of acyclovir (400 mg PO BID) for HSV-2 suppression compared to taking no medication to better define the effect of acyclovir on short bursts of rapidly cleared HSV-2 shedding. This study will be a randomized, open label, cross-over trial. We hypothesize that short bursts of HSV-2 reactivation will not be suppressed by acyclovir.
Linked Publications
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Standard-dose and high-dose daily antiviral therapy for short episodes of genital HSV-2 reactivation: three randomised, open-label, cross-over trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of HSV-2 Total Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per-day Shedding Rate in Participants Treated With Suppressive Acyclovir as Compared to no Medication in HIV Seronegative and HIV Seropositive Individuals. |
24; 3; 15; 7 | <0.001 sig |
| SECONDARY Quantity of HSV Detected, Median |
3.3; 2.9; 5.4; 3.3 | — |
| SECONDARY Number of Genital HSV Shedding Episodes |
49; 17; 20; 17 | — |
| SECONDARY Duration of Genital HSV Shedding Episodes |
13; 7; 6; 8 | — |
Eligibility Criteria
Inclusion Criteria
COHORT 1: HIV seronegative
- Older than 18 years;
- HSV-2 seropositive by Western Blot;
- not receiving any drugs with known anti-HSV-2 activity for study duration;
- women of child bearing potential who are sexually active with men must be using a medically accepted method of contraception as judged by the investigator;
- women of child-bearing potential must have a negative pregnancy test (urine) at screening visit;
- in general good health, without other serious medical conditions and specifically with normal renal and hepatic function, as determined by the patient's medical history;
- planning to remain resident in the area of the study center for the duration of the study participation;
- HIV seronegative
COHORT 2: HIV seropositive
- Older than18 years;
- HSV-2 seropositive by Western Blot;
- not receiving any drugs with known anti-HSV-2 activity for study duration;
- women of child bearing potential who are sexually active with men must be using a medically accepted method of contraception as judged by the investigator;
- women of child-bearing potential must have a negative pregnancy test (urine) at screening visit;
- in general good health, without other serious medical conditions and specifically with normal renal and hepatic function, as determined by the patient's medical history;
- planning to remain resident in the area of the study center for the duration of the study participation;
- HIV seropositive
- CD4 count over 250 cell/mm3
- Not taking antiretroviral therapy
Exclusion Criteria
For both cohorts:
- hypersensitivity to acyclovir or valacyclovir;
- pregnant women;
- Taking immunosuppressive therapies, such as chronic oral steroids or immune modulatory drugs.
For cohort 2:
- CD4 count<250 cell/mm3
- Taking antiretroviral therapy at the time of study entry
Data sourced from ClinicalTrials.gov (NCT00723229) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.