Completed
A Pilot Study to Determine the Effect of Acyclovir Treatment for Herpes Simplex Virus (HSV) Infection on Peripheral Blood HIV Viral Load.
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2016-10-31
75
Participants Needed
15
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Effect of Acyclovir Treatment of the Herpes Simplex Virus (HSV) Infection on HIV Levels in the Blood
Who Can Participate
Eligibility Criteria
You may qualify if you...
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 15 locations
1
AIDS Research Ctr
Palo Alto, California, United States, 94304
Status Unknown
2
Harbor-UCLA Med Ctr
Torrance, California, United States, 90502
Status Unknown
3
Yale Univ School of Medicine / AIDS Program
New Haven, Connecticut, United States, 06510
Status Unknown
4
North Broward Hosp District
Fort Lauderdale, Florida, United States, 33316
Status Unknown
5
Univ of Miami / Jackson Memorial Hosp
Miami, Florida, United States, 331361094
Status Unknown
6
Univ of Illinois - Chicago
Chicago, Illinois, United States, 60612
Status Unknown
7
Univ of Illinois Chicago / Howard Brown Hlth Ctr
Chicago, Illinois, United States, 60612
Status Unknown
8
Johns Hopkins Univ
Baltimore, Maryland, United States, 21205
Status Unknown
9
SUNY Brooklyn / SUNY Health Sciences Ctr at Brooklyn
Brooklyn, New York, United States, 11203
Status Unknown
10
Community Research Initiative on AIDS
New York, New York, United States, 10001
Status Unknown
11
NYU - Bellevue Hosp
New York, New York, United States, 10016
Status Unknown
12
New York Med College / Westchester County Med Ctr
Valhalla, New York, United States, 10595
Status Unknown
13
Research and Education Group
Portland, Oregon, United States, 97210
Status Unknown
14
Univ of Pennsylvania Med Ctr
Philadelphia, Pennsylvania, United States, 19104
Status Unknown
15
Brown Univ / The Miriam Hosp
Providence, Rhode Island, United States, 02906
Status Unknown
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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