The Effect of Acyclovir Treatment of the Herpes Simplex Virus (HSV) Infection on HIV Levels in the Blood
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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 |
---|---|
Herpes Simplex HIV Infections |
Drug: Acyclovir |
Study Type: | Interventional |
Study Design: | Endpoint Classification: Efficacy Study Masking: Double-Blind Primary Purpose: Treatment |
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:
- 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.
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 | |
SUNY Brooklyn / SUNY Health Sciences Ctr at Brooklyn | |
Brooklyn, New York, United States, 11203 | |
Community Research Initiative on AIDS | |
New York, New York, United States, 10001 | |
NYU - Bellevue Hosp | |
New York, New York, United States, 10016 | |
New York Med College / Westchester County Med Ctr | |
Valhalla, New York, United States, 10595 | |
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 |
Additional Information:
No publications provided
ClinicalTrials.gov Identifier: | NCT00001115 History of Changes |
Other Study ID Numbers: | DATRI 020 |
Study First Received: | November 2, 1999 |
Last Updated: | July 28, 2008 |
Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Herpes Simplex Acyclovir Acquired Immunodeficiency Syndrome |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Herpes Simplex Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Slow Virus Diseases Herpesviridae Infections DNA Virus Infections Skin Diseases, Viral Skin Diseases, Infectious Skin Diseases Acyclovir Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on March 10, 2013