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.
1 other identifier
interventional
75
1 country
15
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2005
CompletedOctober 31, 2016
June 1, 1998
November 2, 1999
October 27, 2016
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
AIDS Research Ctr
Palo Alto, California, 94304, United States
Harbor-UCLA Med Ctr
Torrance, California, 90502, United States
Yale Univ School of Medicine / AIDS Program
New Haven, Connecticut, 06510, United States
North Broward Hosp District
Fort Lauderdale, Florida, 33316, United States
Univ of Miami / Jackson Memorial Hosp
Miami, Florida, 331361094, United States
Univ of Illinois - Chicago
Chicago, Illinois, 60612, United States
Univ of Illinois Chicago / Howard Brown Hlth Ctr
Chicago, Illinois, 60612, United States
Johns Hopkins Univ
Baltimore, Maryland, 21205, United States
SUNY Brooklyn / SUNY Health Sciences Ctr at Brooklyn
Brooklyn, New York, 11203, United States
Community Research Initiative on AIDS
New York, New York, 10001, United States
NYU - Bellevue Hosp
New York, New York, 10016, United States
New York Med College / Westchester County Med Ctr
Valhalla, New York, 10595, United States
Research and Education Group
Portland, Oregon, 97210, United States
Univ of Pennsylvania Med Ctr
Philadelphia, Pennsylvania, 19104, United States
Brown Univ / The Miriam Hosp
Providence, Rhode Island, 02906, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Cohn J
- STUDY CHAIR
Mole L
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- NIH
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Primary Completion
June 1, 2005
Study Completion
June 1, 2005
Last Updated
October 31, 2016
Record last verified: 1998-06