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Home > "T" Clinical Trials Conditions > The Effect of Acyclovir Treatment of the Herpes Simplex Virus (HSV) Infection on HIV Levels in the Blood  The Effect of Acyclovir Treatment of the Herpes Simplex Virus (HSV) Infection on HIV Levels in the Blood
The Effect of Acyclovir Treatment of the Herpes Simplex Virus (HSV) Infection on HIV Levels in the Blood
For Condition: Herpes Simplex,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Double-Blind, Efficacy Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 75
Location and Contact Information:
Overall Study Official:
CohnJ, Study Chair,
Research and Education Group
Portland, Oregon, 97210
United States
New York Med College / Westchester County Med Ctr
Valhalla, New York, 10595
United States
AIDS Research Ctr
Palo Alto, California, 94304
United States
Univ of Miami / Jackson Memorial Hosp
Miami, Florida, 331361094
United States
Harbor-UCLA Med Ctr
Torrance, California, 90502
United States
Univ of Illinois - Chicago
Chicago, Illinois, 60612
United States
Univ of Illinois Chicago / Howard Brown Hlth Ctr
Chicago, Illinois, 60612
United States
Johns Hopkins Univ
Baltimore, Maryland, 21205
United States
Community Research Initiative on AIDS
New York City, New York, 10001
United States
Brown Univ / The Miriam Hosp
Providence, Rhode Island, 02906
United States
Yale Univ School of Medicine / AIDS Program
New Haven, Connecticut, 06510
United States
SUNY Brooklyn / SUNY Health Sciences Ctr at Brooklyn
Brooklyn, New York, 11203
United States
Univ of Pennsylvania Med Ctr
Philadelphia, Pennsylvania, 19104
United States
North Broward Hosp District
Ft. Lauderdale, Florida, 33316
United States
NYU - Bellevue Hosp
New York City, New York, 10016
United States
Additional Information:
Study ID Numbers: DATRI 020;
Study Start Date:
Record last reviewed: June 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001115
Other Hiv Infections Studies:
1. The Safety and Effectiveness of Valacyclovir HCl in the Treatment of Herpes Simplex or Varicella/Zoster Infections in HIV-1 Infected Children
2. Herpetic Eye Disease Study (HEDS) II
3. Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Involving the Central Nervous System
4. The Tolerance of HIV-Infected Patients with Herpes Group Virus Infections to Oral Doses of FIAU
5. The Pilot Study of Foscarnet Cream in the Treatment of Mucocutaneous Herpes Simplex Virus Infections in Immunocompromised Patients Unresponsive to Acyclovir Treatment
Related Studies:
Other HIV Infections Clinical Trials
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Other Torrance Clinical Trials
The Effect of Acyclovir Treatment of the Herpes Simplex Virus (HSV) Infection on HIV Levels in the Blood
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