- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001115
The Effect of Acyclovir Treatment of the Herpes Simplex Virus (HSV) Infection on HIV Levels in the Blood
A Pilot Study to Determine the Effect of Acyclovir Treatment for Herpes Simplex Virus (HSV) Infection on Peripheral Blood HIV Viral Load.
Part A: To evaluate the impact of HSV suppression with acyclovir ( ACV ) on HIV burden in patients with asymptomatic HSV infection and at high risk for HSV reactivation.
Part B: To characterize the change in plasma HIV RNA levels and other measures of HIV burden during and after a 10 day course of ACV treatment for acute HSV infection.
Approximately 70% of patients infected with HIV are concurrently infected with HSV. There is new evidence to suggest that HSV may act as a co-factor in HIV disease progression. This study will attempt to determine if the upregulation of HIV RNA that occurs during symptomatic HSV reactivation also occurs during asymptomatic HSV reactivation and if suppression of HSV will result in decreased levels of HIV RNA. There is a need to determine the patterns of association between HSV and HIV.
Study Overview
Detailed Description
Approximately 70% of patients infected with HIV are concurrently infected with HSV. There is new evidence to suggest that HSV may act as a co-factor in HIV disease progression. This study will attempt to determine if the upregulation of HIV RNA that occurs during symptomatic HSV reactivation also occurs during asymptomatic HSV reactivation and if suppression of HSV will result in decreased levels of HIV RNA. There is a need to determine the patterns of association between HSV and HIV.
Part A: 60 approved HIV infected patients will be randomized to either suppressive ACV therapy or matching placebo for 12 weeks. Serology for HSV serum antibodies will be obtained at screening and a full history and physical exam will be performed on Day 1 and interval examinations at Weeks 2, 4, 8 and 12. Extensive clinical exams will be conducted on a regular schedule throughout the 12 weeks.
Part B: 15 approved HIV infected patients will receive treatment with ACV until resolution of the lesion. All patients will be monitored on Day 9-12 of ACV therapy for crusting and resolutions of HSV lesions and will be followed for 3.5 months.
AS PER AMENDMENT 3/11/97: Noncommercial active acyclovir will be made available for Part A patients wo develop acute HSV while on study and for Part B patients who develop acute HSV after completion of the acute phase of treatment ( i.e., during the follow-up phase).
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Palo Alto, California, United States, 94304
- AIDS Research Ctr
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Torrance, California, United States, 90502
- Harbor-UCLA Med Ctr
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Connecticut
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New Haven, Connecticut, United States, 06510
- Yale Univ School of Medicine / AIDS Program
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Florida
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Fort Lauderdale, Florida, United States, 33316
- North Broward Hosp District
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Miami, Florida, United States, 331361094
- Univ of Miami / Jackson Memorial Hosp
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Illinois
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Chicago, Illinois, United States, 60612
- Univ of Illinois - Chicago
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Chicago, Illinois, United States, 60612
- Univ of Illinois Chicago / Howard Brown Hlth Ctr
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Maryland
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Baltimore, Maryland, United States, 21205
- Johns Hopkins Univ
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New York
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Brooklyn, New York, United States, 11203
- SUNY Brooklyn / SUNY Health Sciences Ctr at Brooklyn
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New York, New York, United States, 10001
- Community Research Initiative on AIDS
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New York, New York, United States, 10016
- NYU - Bellevue Hosp
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Valhalla, New York, United States, 10595
- New York Med College / Westchester County Med Ctr
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Oregon
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Portland, Oregon, United States, 97210
- Research and Education Group
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Univ of Pennsylvania Med Ctr
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Rhode Island
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Providence, Rhode Island, United States, 02906
- Brown Univ / The Miriam Hosp
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
Patients must have:
Parts A and B:
- Documented HIV infection.
- Patients >= 18 years of age must be willing and able to give informed consent and patients < 18 years must have written consent from a parent or guardian.
Part A:
- CD4+ T count < 250 cells/mm3 within 1 month prior to study entry.
- Documented antibodies to HSV any time prior to study.
- History of HSV outbreak in past 2 to 12 months.
- Former Part B patients who have completed the 12 week follow up may enter Part A after at least a 4-week washout.
Part B:
- Documented CD4+ T count < 250 cells/mm3 anytime prior to study entry.
- Oral, genital or anorectal lesions with a vesiculopustular component.
- Presumptive diagnosis of HSV.
- Former part A patients may enter part B after a 4-week washout.
Exclusion Criteria
Patients with any of the following prior conditions are excluded:
- Documented or suspected HSV within 2 months prior to study entry.
- History of infection with an acyclovir resistant HSV strain.
- History of disseminated HSV.
- History of treatment for acute CMV or MAC disease.
- History of poor medication or clinic visit compliance.
Prior Medication:
Excluded:
- Use of acyclovir, famciclovir, foscarnet, ganciclovir, valacyclovir or cidofovir for any reason within one month prior to study entry. [AS PER AMENDMENT 1/21/97: Use of antiherpes agents, both FDA-approved and investigational, including bis-POM, PMEA, lobucavir, acyclovir, etc.]
- Initiation or modification of antiretroviral therapy, immunomodulators, or any kind of vaccination within 2 months prior to study entry.
- Treatment for acute medical condition within 4 weeks prior to study entry.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Masking: DOUBLE
Collaborators and Investigators
Investigators
- Study Chair: Mole L
Study record dates
Study Major Dates
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DATRI 020
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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