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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00001115
First received: November 2, 1999
Last updated: July 28, 2008
Last verified: June 1998
  Purpose

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 Intervention
Herpes Simplex
HIV Infections
Drug: Acyclovir

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Masking: Double-Blind
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.

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 75
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).

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001115

Locations
United States, California
AIDS Research Ctr
Palo Alto, California, United States, 94304
Harbor-UCLA Med Ctr
Torrance, California, United States, 90502
United States, Connecticut
Yale Univ School of Medicine / AIDS Program
New Haven, Connecticut, United States, 06510
United States, Florida
North Broward Hosp District
Fort Lauderdale, Florida, United States, 33316
Univ of Miami / Jackson Memorial Hosp
Miami, Florida, United States, 331361094
United States, Illinois
Univ of Illinois - Chicago
Chicago, Illinois, United States, 60612
Univ of Illinois Chicago / Howard Brown Hlth Ctr
Chicago, Illinois, United States, 60612
United States, Maryland
Johns Hopkins Univ
Baltimore, Maryland, United States, 21205
United States, New York
SUNY Brooklyn / SUNY Health Sciences Ctr at Brooklyn
Brooklyn, New York, United States, 11203
Community Research Initiative on AIDS
New York, New York, United States, 10001
NYU - Bellevue Hosp
New York, New York, United States, 10016
New York Med College / Westchester County Med Ctr
Valhalla, New York, United States, 10595
United States, Oregon
Research and Education Group
Portland, Oregon, United States, 97210
United States, Pennsylvania
Univ of Pennsylvania Med Ctr
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
Brown Univ / The Miriam Hosp
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Investigators
Study Chair: Cohn J
Study Chair: Mole L
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00001115     History of Changes
Other Study ID Numbers: DATRI 020
Study First Received: November 2, 1999
Last Updated: July 28, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Herpes Simplex
Acyclovir
Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Herpes Simplex
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Herpesviridae Infections
DNA Virus Infections
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Acyclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014