Status:

COMPLETED

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

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

Herpes Simplex

HIV Infections

Eligibility:

All Genders

13+ years

Phase:

NA

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 c...

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...

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.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

June 1 2005

Estimated Enrollment :

75 Patients enrolled

Trial Details

Trial ID

NCT00001115

End Date

June 1 2005

Last Update

October 31 2016

Active Locations (15)

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Page 1 of 4 (15 locations)

1

AIDS Research Ctr

Palo Alto, California, United States, 94304

2

Harbor-UCLA Med Ctr

Torrance, California, United States, 90502

3

Yale Univ School of Medicine / AIDS Program

New Haven, Connecticut, United States, 06510

4

North Broward Hosp District

Fort Lauderdale, Florida, United States, 33316