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

Primary Purpose

Herpes Simplex, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acyclovir
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Herpes Simplex focused on measuring Herpes Simplex, Acyclovir, Acquired Immunodeficiency Syndrome

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • AIDS Research Ctr
  • Harbor-UCLA Med Ctr
  • Yale Univ School of Medicine / AIDS Program
  • North Broward Hosp District
  • Univ of Miami / Jackson Memorial Hosp
  • Univ of Illinois - Chicago
  • Univ of Illinois Chicago / Howard Brown Hlth Ctr
  • Johns Hopkins Univ
  • SUNY Brooklyn / SUNY Health Sciences Ctr at Brooklyn
  • Community Research Initiative on AIDS
  • NYU - Bellevue Hosp
  • New York Med College / Westchester County Med Ctr
  • Research and Education Group
  • Univ of Pennsylvania Med Ctr
  • Brown Univ / The Miriam Hosp

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 27, 2016
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00001115
Brief Title
The Effect of Acyclovir Treatment of the Herpes Simplex Virus (HSV) Infection on HIV Levels in the Blood
Official Title
A Pilot Study to Determine the Effect of Acyclovir Treatment for Herpes Simplex Virus (HSV) Infection on Peripheral Blood HIV Viral Load.
Study Type
Interventional

2. Study Status

Record Verification Date
June 1998
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Simplex, HIV Infections
Keywords
Herpes Simplex, Acyclovir, Acquired Immunodeficiency Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
Double
Enrollment
75 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Acyclovir

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cohn J
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mole L
Official's Role
Study Chair
Facility Information:
Facility Name
AIDS Research Ctr
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Harbor-UCLA Med Ctr
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Yale Univ School of Medicine / AIDS Program
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
North Broward Hosp District
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Univ of Miami / Jackson Memorial Hosp
City
Miami
State/Province
Florida
ZIP/Postal Code
331361094
Country
United States
Facility Name
Univ of Illinois - Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Univ of Illinois Chicago / Howard Brown Hlth Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Johns Hopkins Univ
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
SUNY Brooklyn / SUNY Health Sciences Ctr at Brooklyn
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Community Research Initiative on AIDS
City
New York
State/Province
New York
ZIP/Postal Code
10001
Country
United States
Facility Name
NYU - Bellevue Hosp
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
New York Med College / Westchester County Med Ctr
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Research and Education Group
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Univ of Pennsylvania Med Ctr
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Brown Univ / The Miriam Hosp
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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