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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT00001115

Collaborator

(none)

Enrollment

Locations

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Herpes Simplex HIV Infections	Drug: Acyclovir	N/A

Detailed Description

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).

Study Design

Study Type:

Interventional

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Pilot Study to Determine the Effect of Acyclovir Treatment for Herpes Simplex Virus (HSV) Infection on Peripheral Blood HIV Viral Load.

Actual Primary Completion Date :

Jun 1, 2005

Actual Study Completion Date :

Jun 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	Univ of Miami / Jackson Memorial Hosp	Miami	Florida	United States	331361094
6	Univ of Illinois - Chicago	Chicago	Illinois	United States	60612
7	Univ of Illinois Chicago / Howard Brown Hlth Ctr	Chicago	Illinois	United States	60612
8	Johns Hopkins Univ	Baltimore	Maryland	United States	21205
9	SUNY Brooklyn / SUNY Health Sciences Ctr at Brooklyn	Brooklyn	New York	United States	11203
10	Community Research Initiative on AIDS	New York	New York	United States	10001
11	NYU - Bellevue Hosp	New York	New York	United States	10016
12	New York Med College / Westchester County Med Ctr	Valhalla	New York	United States	10595
13	Research and Education Group	Portland	Oregon	United States	97210
14	Univ of Pennsylvania Med Ctr	Philadelphia	Pennsylvania	United States	19104
15	Brown Univ / The Miriam Hosp	Providence	Rhode Island	United States	02906