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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00001115 |
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 |
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Herpes Simplex HIV Infections |
Drug: Acyclovir |
Study Type: | Interventional |
Study Design: | Treatment, Double-Blind, Efficacy Study |
Official Title: | A Pilot Study to Determine the Effect of Acyclovir Treatment for Herpes Simplex Virus (HSV) Infection on Peripheral Blood HIV Viral Load. |
Estimated Enrollment: | 75 |
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).
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Parts A and B:
Part A:
Part B:
Exclusion Criteria
Patients with any of the following prior conditions are excluded:
Prior Medication:
Excluded:
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 | |
New York Med College / Westchester County Med Ctr | |
Valhalla, New York, United States, 10595 | |
SUNY Brooklyn / SUNY Health Sciences Ctr at Brooklyn | |
Brooklyn, New York, United States, 11203 | |
NYU - Bellevue Hosp | |
New York, New York, United States, 10016 | |
Community Research Initiative on AIDS | |
New York, New York, United States, 10001 | |
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 |
Study Chair: | Cohn J | |
Study Chair: | Mole L |
Study ID Numbers: | DATRI 020 |
Study First Received: | November 2, 1999 |
Last Updated: | July 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00001115 |
Health Authority: | United States: Federal Government |
Herpes Simplex Acyclovir Acquired Immunodeficiency Syndrome |
Herpes Simplex Sexually Transmitted Diseases, Viral Skin Diseases Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes Herpesviridae Infections Virus Diseases |
Skin Diseases, Infectious Acyclovir HIV Infections Sexually Transmitted Diseases DNA Virus Infections Retroviridae Infections |
Skin Diseases, Viral Anti-Infective Agents Communicable Diseases RNA Virus Infections Slow Virus Diseases Immune System Diseases |
Therapeutic Uses Lentivirus Infections Infection Antiviral Agents Pharmacologic Actions |