Herpes SimplexNCT00001115
The Effect of Acyclovir Treatment of the Herpes Simplex Virus (HSV) Infection on HIV Levels in the Blood
A study testing Acyclovir in people with Herpes Simplex and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 15 sites in United States.
Trial 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 change in plasma HIV RNA levels and other measures of HIV burden during and after a 10 day course of ACV treatment for… Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Herpes Simplex, HIV Infections
- What is being tested?
- Acyclovir
- How many people
- 75 participants
- Where
- 15 sitesUnited States
- Study dates
- Start not givento Jun 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Johns Hopkins Univ
Baltimore, Maryland, 21205
SUNY Brooklyn / SUNY Health Sciences Ctr at Brooklyn
Brooklyn, New York, 11203
Univ of Illinois - Chicago
Chicago, Illinois, 60612
Univ of Illinois Chicago / Howard Brown Hlth Ctr
Chicago, Illinois, 60612
North Broward Hosp District
Fort Lauderdale, Florida, 33316
Univ of Miami / Jackson Memorial Hosp
Miami, Florida, 331361094
Yale Univ School of Medicine / AIDS Program
New Haven, Connecticut, 06510
Community Research Initiative on AIDS
New York, New York, 10001
NYU - Bellevue Hosp
New York, New York, 10016
AIDS Research Ctr
Palo Alto, California, 94304
Univ of Pennsylvania Med Ctr
Philadelphia, Pennsylvania, 19104
Research and Education Group
Portland, Oregon, 97210
Brown Univ / The Miriam Hosp
Providence, Rhode Island, 02906
Harbor-UCLA Med Ctr
Torrance, California, 90502
New York Med College / Westchester County Med Ctr
Valhalla, New York, 10595
About this 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.
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.
Read the 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 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).
- Conditions
- Herpes Simplex, HIV Infections
- Being tested
- Acyclovir
- Keywords
- Herpes Simplex, Acyclovir, Acquired Immunodeficiency Syndrome
- Medical subject headings
- Herpes Simplex, HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcyclovirDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Primary completionJun 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes SimplexStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Masking
- Double blind
- Enrolment
- 75 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Cohn J, Study chairMole L, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001115
- Sponsor's protocol ID
- DATRI 020
- Status last verified
- Jun 1998
- First submitted
- 2 Nov 1999
- Last updated
- 31 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Determine the Effect of Acyclovir Treatment for Herpes Simplex Virus (HSV) Infection on Peripheral Blood HIV Viral Load.
- ClinicalTrials.gov ID
- NCT00001115
- Acronym / sponsor ID
- DATRI 020
- Conditions
- Herpes Simplex, HIV Infections
- Keywords
- Herpes Simplex, Acyclovir, Acquired Immunodeficiency Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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).
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acyclovir | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cohn J study chair
Mole L study chair
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acyclovir in people with Herpes Simplex and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2016.