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

NCT ID: NCT00001115

Last Updated: 2016-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Completion Date: 2005-06-30

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).

Conditions

Herpes Simplex; HIV Infections

Keywords

Herpes Simplex; Acyclovir; Acquired Immunodeficiency Syndrome

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Acyclovir

Intervention Type: DRUG

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.

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Principal Investigators

Cohn J

Role: STUDY_CHAIR

Mole L

Role: STUDY_CHAIR

Locations

AIDS Research Ctr

Palo Alto, California, United States

Harbor-UCLA Med Ctr

Torrance, California, United States

Yale Univ School of Medicine / AIDS Program

New Haven, Connecticut, United States

North Broward Hosp District

Fort Lauderdale, Florida, United States

Univ of Miami / Jackson Memorial Hosp

Miami, Florida, United States

Univ of Illinois - Chicago

Chicago, Illinois, United States

Univ of Illinois Chicago / Howard Brown Hlth Ctr

Chicago, Illinois, United States

Johns Hopkins Univ

Baltimore, Maryland, United States

SUNY Brooklyn / SUNY Health Sciences Ctr at Brooklyn

Brooklyn, New York, United States

Community Research Initiative on AIDS

New York, New York, United States

NYU - Bellevue Hosp

New York, New York, United States

New York Med College / Westchester County Med Ctr

Valhalla, New York, United States

Research and Education Group

Portland, Oregon, United States

Univ of Pennsylvania Med Ctr

Philadelphia, Pennsylvania, United States

Brown Univ / The Miriam Hosp

Providence, Rhode Island, United States

Countries

United States

Other Identifiers

DATRI 020

Identifier Type: -

Identifier Source: org_study_id