Herpes SimplexNCT00000635
Treatment of Acyclovir-Resistant Mucocutaneous Herpes Simplex Disease in Patients With AIDS: Open Label Pilot Study of Topical Trifluridine
A study testing Trifluridine and Bacitracin zinc/Polymyxin B sulfate in people with Herpes Simplex and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 sites in United States.
Trial summary
To determine the safety, effectiveness, and toxicity of topical (local) trifluridine in treating mucocutaneous (at the nasal, oral, vaginal, and anal openings) Herpes simplex virus ( HSV ) disease that has shown resistance to acyclovir in HIV-infected patients. 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?
- Trifluridine and Bacitracin zinc/Polymyxin B sulfate
- How many people
- 25 participants
- Where
- 8 sitesUnited States
- Study dates
- Start not givento Apr 1992
- 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
- Concurrent Medication: Included:
- All medications deemed essential for best patient care, including zidovudine (AZT), Pneumocystis carinii pneumonia (PCP) prophylaxis, and acute or maintenance therapies for other opportunistic infections.
- Patients must have the following:
- HIV infection or diagnosis of AIDS.
- Mucocutaneous Herpes simplex virus infection.
- Ability to give informed consent.
- Allowed:
- Patients may be co-enrolled in other ACTG studies except for those in which treatments are expected to generate neutropenia. Subjects aged 13 - 17 may be enrolled with appropriate consent from parent or guardian.
Who cannot join
- Concurrent Medication:
- Excluded:
- Acyclovir, ganciclovir, foscarnet, vidarabine or other investigational drugs with potential anti-Herpes simplex virus activity.
- Patients with the following are excluded:
- Previous hypersensitivity reaction to trifluridine, polymyxin B or bacitracin.
- Prior Medication:
- Excluded:
- Immunomodulators, lymphocyte replacement therapy or biologic response modifiers within 14 days prior to study entry.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Colorado Hospital CRS
Aurora, Colorado
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, 21287
Cook County Hosp. CORE Ctr.
Chicago, Illinois
Northwestern University CRS
Chicago, Illinois
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois
NY Univ. HIV/AIDS CRS
New York, New York, 10016
Ucsf Aids Crs
San Francisco, California
Washington U CRS
St Louis, Missouri
About this study
To determine the safety, effectiveness, and toxicity of topical (local) trifluridine in treating mucocutaneous (at the nasal, oral, vaginal, and anal openings) Herpes simplex virus ( HSV ) disease that has shown resistance to acyclovir in HIV-infected patients. HSV infection in patients with AIDS is often associated with skin sores and frequent recurrences. Treatment with the drug acyclovir results in healing for most patients, but repeated treatment sometimes results in resistance of the virus to acyclovir. Thus, when this happens, other treatments need to be used. Trifluridine is an antiviral drug that is used for the treatment of Herpes infections that occur in the eye. This study attempts to determine if trifluridine is useful for treating HSV sores that have not healed after treatment with acyclovir.
Read the detailed description
HSV infection in patients with AIDS is often associated with skin sores and frequent recurrences. Treatment with the drug acyclovir results in healing for most patients, but repeated treatment sometimes results in resistance of the virus to acyclovir. Thus, when this happens, other treatments need to be used. Trifluridine is an antiviral drug that is used for the treatment of Herpes infections that occur in the eye. This study attempts to determine if trifluridine is useful for treating HSV sores that have not healed after treatment with acyclovir.
Patients receive at least 10 days (and up to 42 days) of treatment with topical trifluridine. Trifluridine is applied in a thin fluid layer that overlaps the edges of the lesion. Polymyxin B sulfate/bacitracin zinc ointment is then applied over the trifluridine. Lesions are covered by a nonabsorbent dressing. Medication is applied every 8 hours.
- Conditions
- Herpes Simplex, HIV Infections
- Being tested
- Trifluridine, Bacitracin zinc/Polymyxin B sulfate
- Keywords
- Bacitracin, Polymyxin B, Trifluridine, AIDS-Related Opportunistic Infections, Herpesviridae Infections, Drug Evaluation, Acquired Immunodeficiency Syndrome, Anti-Infective Agents, Local, Antiviral Agents
- Medical subject headings
- Herpes Simplex, HIV Infections, AIDS-Related Opportunistic Infections, Herpesviridae Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrifluridineDrug
Bacitracin zinc/Polymyxin B sulfateDrug
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)
- Study completionApr 1992
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- None (open label)
- Enrolment
- 25 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Glaxo Wellcome
- Responsible party
- Sponsor
- Investigators
- Kessler H A, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000635
- Sponsor's protocol ID
- ACTG 172
- Other IDs
- 11147
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 2 Nov 2021
- Results posted
- No
Publications
Kessler H, Weaver D, Benson C, Pottage J, Safrin S, Nevin T, Davis R, Owens S, Korvick J. ACTG 172: treatment of acyclovir-resistant (ACV-R) mucocutaneous herpes simplex virus (HSV) infection in patients with AIDS: open label pilot study of topical trifluridine (TFT). Int Conf AIDS. 1992 Jul 19-24;8(1):We55 (abstract no WeB 1056)
Kessler HA, Hurwitz S, Farthing C, Benson CA, Feinberg J, Kuritzkes DR, Bailey TC, Safrin S, Steigbigel RT, Cheeseman SH, McKinley GF, Wettlaufer B, Owens S, Nevin T, Korvick JA. Pilot study of topical trifluridine for the treatment of acyclovir-resistant mucocutaneous herpes simplex disease in patients with AIDS (ACTG 172). AIDS Clinical Trials Group. J Acquir Immune Defic Syndr Hum Retrovirol. 1996 Jun 1;12(2):147-52. doi: 10.1097/00042560-199606010-00007.
PubMed 8680885
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Acyclovir-Resistant Mucocutaneous Herpes Simplex Disease in Patients With AIDS: Open Label Pilot Study of Topical Trifluridine
- ClinicalTrials.gov ID
- NCT00000635
- Acronym / sponsor ID
- ACTG 172
- Conditions
- Herpes Simplex, HIV Infections
- Keywords
- Bacitracin, Polymyxin B, Trifluridine, AIDS-Related Opportunistic Infections, Herpesviridae Infections, Drug Evaluation, Acquired Immunodeficiency Syndrome, Anti-Infective Agents, Local
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Glaxo Wellcome
- Study completion
- Apr 1992 (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.
To determine the safety, effectiveness, and toxicity of topical (local) trifluridine in treating mucocutaneous (at the nasal, oral, vaginal, and anal openings) Herpes simplex virus ( HSV ) disease that has shown resistance to acyclovir in HIV-infected patients. HSV infection in patients with AIDS is often associated with skin sores and frequent recurrences. Treatment with the drug acyclovir results in healing for most patients, but repeated treatment sometimes results in resistance of the virus to acyclovir. Thus, when this happens, other treatments need to be used. Trifluridine is an antiviral drug that is used for the treatment of Herpes infections that occur in the eye. This study attempts to determine if trifluridine is useful for treating HSV sores that have not healed after treatment with acyclovir.
Detailed description
HSV infection in patients with AIDS is often associated with skin sores and frequent recurrences. Treatment with the drug acyclovir results in healing for most patients, but repeated treatment sometimes results in resistance of the virus to acyclovir. Thus, when this happens, other treatments need to be used. Trifluridine is an antiviral drug that is used for the treatment of Herpes infections that occur in the eye. This study attempts to determine if trifluridine is useful for treating HSV sores that have not healed after treatment with acyclovir.
Patients receive at least 10 days (and up to 42 days) of treatment with topical trifluridine. Trifluridine is applied in a thin fluid layer that overlaps the edges of the lesion. Polymyxin B sulfate/bacitracin zinc ointment is then applied over the trifluridine. Lesions are covered by a nonabsorbent dressing. Medication is applied every 8 hours.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- All medications deemed essential for best patient care, including zidovudine (AZT), Pneumocystis carinii pneumonia (PCP) prophylaxis, and acute or maintenance therapies for other opportunistic infections.
- HIV infection or diagnosis of AIDS.
- Mucocutaneous Herpes simplex virus infection.
- Ability to give informed consent.
- Patients may be co-enrolled in other ACTG studies except for those in which treatments are expected to generate neutropenia. Subjects aged 13 - 17 may be enrolled with appropriate consent from parent or guardian.
Key exclusion criteria (8 listed)
- Acyclovir, ganciclovir, foscarnet, vidarabine or other investigational drugs with potential anti-Herpes simplex virus activity.
- Previous hypersensitivity reaction to trifluridine, polymyxin B or bacitracin.
- Immunomodulators, lymphocyte replacement therapy or biologic response modifiers within 14 days prior to study entry.
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 |
|---|---|---|
| Trifluridine | Drug | – |
| Bacitracin zinc/Polymyxin B sulfate | 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 2 Nov 2021.
- BackgroundKessler H, Weaver D, Benson C, Pottage J, Safrin S, Nevin T, Davis R, Owens S, Korvick J. ACTG 172: treatment of acyclovir-resistant (ACV-R) mucocutaneous herpes simplex virus (HSV) infection in patients with AIDS: open label pilot study of topical trifluridine (TFT). Int Conf AIDS. 1992 Jul 19-24;8(1):We55 (abstract no WeB 1056)
- Background: PubMed 8680885Kessler HA, Hurwitz S, Farthing C, Benson CA, Feinberg J, Kuritzkes DR, Bailey TC, Safrin S, Steigbigel RT, Cheeseman SH, McKinley GF, Wettlaufer B, Owens S, Nevin T, Korvick JA. Pilot study of topical trifluridine for the treatment of acyclovir-resistant mucocutaneous herpes simplex disease in patients with AIDS (ACTG 172). AIDS Clinical Trials Group. J Acquir Immune Defic Syndr Hum Retrovirol. 1996 Jun 1;12(2):147-52. doi: 10.1097/00042560-199606010-00007.
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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.
Kessler H A study chair
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trifluridine and Bacitracin zinc/Polymyxin B sulfate in people with Herpes Simplex and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 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 8 inclusion and 8 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 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
On the ClinicalTrials.gov record for NCT00000635, which also lists 2 linked publications.
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 2 Nov 2021.