A Randomized Trial to Evaluated the Suppressive Effect of Acyclovir on Rapidly Cleared HSV-2 Reactivation

NCT ID: NCT00723229

Last Updated: 2017-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2011-09-30

Brief 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.

Detailed Description

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 propose to perform this study in two study populations. Cohort 1 will be comprised of 25 HSV-2 seropositive, HIV seronegative adults, and Cohort 2 will be comprised of 25 HSV-2 seropositive, HIV seropositive adults with a CD4 count>250 cells/mm3. As suppression of HSV-2 using acyclovir is currently being studied in large, multi-center, international clinical trials as an HIV prevention strategy, these results will have broad implications for public health around the world.

Conditions

Genital Herpes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: ACTIVE_COMPARATOR

acyclovir

Intervention Type: DRUG

Acyclovir 400 mg PO BID for 28 days

2

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

acyclovir

Acyclovir 400 mg PO BID for 28 days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

COHORT 1: HIV seronegative

1. Older than 18 years;

2. HSV-2 seropositive by Western Blot;

3. not receiving any drugs with known anti-HSV-2 activity for study duration;

4. 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;

5. women of child-bearing potential must have a negative pregnancy test (urine) at screening visit;

6. 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;

7. planning to remain resident in the area of the study center for the duration of the study participation;

8. HIV seronegative

COHORT 2: HIV seropositive

1. Older than18 years;

2. HSV-2 seropositive by Western Blot;

3. not receiving any drugs with known anti-HSV-2 activity for study duration;

4. 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;

5. women of child-bearing potential must have a negative pregnancy test (urine) at screening visit;

6. 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;

7. planning to remain resident in the area of the study center for the duration of the study participation;

8. HIV seropositive

9. CD4 count over 250 cell/mm3

10. Not taking antiretroviral therapy

Exclusion Criteria

For both cohorts:

1. hypersensitivity to acyclovir or valacyclovir;

2. pregnant women;

3. Taking immunosuppressive therapies, such as chronic oral steroids or immune modulatory drugs.

For cohort 2:

1. CD4 count<250 cell/mm3

2. Taking antiretroviral therapy at the time of study entry

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Christine Johnston

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christine Johnston, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington Virology Research Clinic

Seattle, Washington, United States

Countries

United States

References

Johnston C, Saracino M, Kuntz S, Magaret A, Selke S, Huang ML, Schiffer JT, Koelle DM, Corey L, Wald A. Standard-dose and high-dose daily antiviral therapy for short episodes of genital HSV-2 reactivation: three randomised, open-label, cross-over trials. Lancet. 2012 Feb 18;379(9816):641-7. doi: 10.1016/S0140-6736(11)61750-9. Epub 2012 Jan 4.

Reference Type: DERIVED

PMID: 22225814 (View on PubMed)

Other Identifiers

U19AI031448

Identifier Type: NIH

Identifier Source: secondary_id

View Link

34187-B

Identifier Type: -

Identifier Source: org_study_id