Search / Trial NCT00001115

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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of December 10, 2023

Completed

Keywords

Herpes Simplex Acyclovir Acquired Immunodeficiency Syndrome

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...

Gender

All

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.

Attachments

readout_NCT00001115_2023-12-10.pdf

4.5 MB

NCT00001115_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Miami, Florida, United States

Fort Lauderdale, Florida, United States

New York, New York, United States

Valhalla, New York, United States

Philadelphia, Pennsylvania, United States

Baltimore, Maryland, United States

New Haven, Connecticut, United States

Chicago, Illinois, United States

Palo Alto, California, United States

Torrance, California, United States

Chicago, Illinois, United States

Brooklyn, New York, United States

New York, New York, United States

Portland, Oregon, United States

Providence, Rhode Island, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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