Status:
COMPLETED
The Effect of Acyclovir Treatment of the Herpes Simplex Virus (HSV) Infection on HIV Levels in the Blood
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Herpes Simplex
HIV Infections
Eligibility:
All Genders
13+ years
Phase:
NA
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 c...
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...
Eligibility 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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
June 1 2005
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00001115
End Date
June 1 2005
Last Update
October 31 2016
Active Locations (15)
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1
AIDS Research Ctr
Palo Alto, California, United States, 94304
2
Harbor-UCLA Med Ctr
Torrance, California, United States, 90502
3
Yale Univ School of Medicine / AIDS Program
New Haven, Connecticut, United States, 06510
4
North Broward Hosp District
Fort Lauderdale, Florida, United States, 33316