The Effect of Acyclovir Treatment of the Herpes Simplex Virus (HSV) Infection on HIV Levels in the Blood
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Herpes Simplex; HIV Infections
Intervention: Acyclovir (Drug)
Phase: N/A
Status: Completed
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID) Official(s) and/or principal investigator(s): Cohn J, Study Chair Mole L, Study Chair
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.
Clinical Details
Official title: A Pilot Study to Determine the Effect of Acyclovir Treatment for Herpes Simplex Virus (HSV) Infection on Peripheral Blood HIV Viral Load.
Study design: Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment
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).
Eligibility
Minimum age: 13 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
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
Additional Information
Last updated: July 28, 2008
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