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Antiviral

Valacyclovir for Genital Herpes in HIV-Infected Patients

Phase 3
Waitlist Available
Research Sponsored by Glaxo Wellcome
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have herpes simplex virus (HSV) 2
Patients must have had 4 or more recurrences of ano-genital HSV in the last 12 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial will test whether the drug Valtrex can safely and effectively treat anal and genital HSV infections in HIV-infected patients.

Who is the study for?
This trial is for adults over 18 with genital herpes (HSV-2) who are also HIV-positive. They must have had at least four flare-ups in the past year and been on anti-HIV therapy for two months. Participants need to commit to birth control during and after the study, unless they can't have children.Check my eligibility
What is being tested?
The study is testing Valacyclovir's safety and effectiveness as a treatment for ano-genital herpes infections in those living with HIV. It aims to see if this medication can help manage symptoms of genital herpes among these patients.See study design
What are the potential side effects?
Valacyclovir may cause side effects like headache, nausea, stomach pain, vomiting, dizziness or kidney problems. In people with weakened immune systems, there might be an increased risk of more serious side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have herpes simplex virus 2.
Select...
I have had 4 or more genital herpes outbreaks in the past year.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Find a Location

Who is running the clinical trial?

Glaxo WellcomeLead Sponsor
120 Previous Clinical Trials
24,430 Total Patients Enrolled

Media Library

Valacyclovir (Antiviral) Clinical Trial Eligibility Overview. Trial Name: NCT00005663 — Phase 3
Herpes Research Study Groups:
Herpes Clinical Trial 2023: Valacyclovir Highlights & Side Effects. Trial Name: NCT00005663 — Phase 3
Valacyclovir (Antiviral) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00005663 — Phase 3
Herpes Patient Testimony for trial: Trial Name: NCT00005663 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are volunteers of all ages needed for this experiment?

"This particular clinical trial is only for patients aged 18 to 0. In total, there are 312 trials recruiting people under the age of 18 and 965 trials for those over 65."

Answered by AI

Are there several clinics running this study in the metropolitan area?

"Currently, this study is running at 24 different sites. Some are in major cities such as Minneapolis, Providence and Charlotte while others are located in more rural areas. To minimize travel commitment, it would be best to select the clinical nearest to your location."

Answered by AI

Does the FDA sanction this medication?

"This clinical trial is in Phase 3, which suggests that while there is data affirming the treatment's efficacy, multiple rounds of testing have also supported its safety. Consequently, our team rates the safety as a 3."

Answered by AI

Are there any unfilled positions in this research project?

"The data available on clinicaltrials.gov suggests that this particular trial is not currently seeking patients. The first posting was on June 1st, 1999 with the most recent edit happening on June 23rd, 2005. There are 1257 other trials which are recruiting patients right now."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Florida
North Carolina
Other
How old are they?
18 - 65
What site did they apply to?
East Bay AIDS Ctr
Advanced Biomedical Research Inc
Baylor College of Medicine / Dept of Medicine
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
3+
0

Why did patients apply to this trial?

the trial and I need it. I saw the trial and I need it. I would like to see if there’s a cure for HSV type 1.
PatientReceived 2+ prior treatments
I am totally broke in my life I want to get rid of this plz help me to cure.
PatientReceived 2+ prior treatments
Tried herpes treatment hoping this clinical trial will help me in curing herpes permanently.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

How soon could I be enrolled in the study?
PatientReceived 1 prior treatment
~14 spots leftby Apr 2025