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

Completed · Not applicable

Conditions studied: Herpes Simplex, HIV Infections

In brief

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.

Key facts

Study ID

NCT00001115

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

75

Expected to finish

2005-06-01

Last updated by the study team

2016-10-31

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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