The Effect of Acyclovir Treatment of the Herpes Simplex Virus (HSV) Infection on HIV Levels in the Blood

Not Applicable

Completed

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.

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).

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Locations (15): Univ of Illinois Chicago / Howard Brown Hlth Ctr
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Chicago, Illinois, United States
Univ of Illinois - Chicago
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Chicago, Illinois, United States
Johns Hopkins Univ
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Baltimore, Maryland, United States
Research and Education Group
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Portland, Oregon, United States
New York Med College / Westchester County Med Ctr
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Valhalla, New York, United States
Univ of Miami / Jackson Memorial Hosp
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Miami, Florida, United States
AIDS Research Ctr
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Palo Alto, California, United States
Harbor-UCLA Med Ctr
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Torrance, California, United States
North Broward Hosp District
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Fort Lauderdale, Florida, United States
Yale Univ School of Medicine / AIDS Program
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New Haven, Connecticut, United States
Community Research Initiative on AIDS
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New York, New York, United States
SUNY Brooklyn / SUNY Health Sciences Ctr at Brooklyn
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Brooklyn, New York, United States
NYU - Bellevue Hosp
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New York, New York, United States
Brown Univ / The Miriam Hosp
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Providence, Rhode Island, United States
Univ of Pennsylvania Med Ctr
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Philadelphia, Pennsylvania, United States