Completed

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

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What is being tested

Acyclovir

Drug
Who is being recruted

Herpes Simplex

+ HIV Infections
Over 13 Years
How is the trial designed

Treatment Study

Interventional

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: October 31, 2016
Sourced from a government-validated database.Claim as a partner

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. 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).

Official TitleA Pilot Study to Determine the Effect of Acyclovir Treatment for Herpes Simplex Virus (HSV) Infection on Peripheral Blood HIV Viral Load. 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: October 31, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
75 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label
: Everyone knows which treatment is being given.

Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 13 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Herpes Simplex
HIV Infections
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.



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 15 locations
Suspended
AIDS Research CtrPalo Alto, United StatesSee the location
Suspended
Harbor-UCLA Med CtrTorrance, United States
Suspended
Yale Univ School of Medicine / AIDS ProgramNew Haven, United States
Suspended
North Broward Hosp DistrictFort Lauderdale, United States

Completed15 Study Centers