Herpes SimplexNCT00002310
SP-303T Applied to the Skin of Patients With Herpes Simplex Virus (HSV) Infection and AIDS Who Have Not Had Success With Acyclovir
A study testing Crofelemer in people with Herpes Simplex and HIV Infections, run by Shaman Pharmaceuticals at 4 sites in United States.
Trial summary
To evaluate the safety and tolerance of topically applied SP-303T in AIDS patients. To observe the effect of this drug on herpes simplex virus lesions in patients who have failed to heal in response to oral or intravenous acyclovir therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Herpes Simplex, HIV Infections
- What is being tested?
- Crofelemer
- How many people
- Not given
- Where
- 4 sitesUnited States
- Study dates
- Start not givento not given
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have:
- HIV-1 infection.
- AIDS.
- Chronic mucocutaneous herpes simplex virus (HSV) infection, with one or more lesions unresponsive to oral acyclovir therapy.
- No uncontrolled infections other than HSV.
- Sufficient mental status to understand the purpose of the study and to comply with study requirements.
- Sufficient general health to be an outpatient and to come to the clinic for required follow-up visits.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Known hypersensitivity or allergy to citrus fruits, black currant berries, and rose hips.
- Any disease condition that, in the opinion of the investigator, would interfere with evaluation of the study drug, affect patient compliance, or place the patient at increased risk.
- Concurrent Medication:
- Excluded:
Show all 10Show fewer
- Other unapproved investigational new drugs.
- Concurrent other therapy for herpes simplex virus (HSV) infection or medications with known activity against HSV.
- Required:
- A minimum of 10 days of prior oral acyclovir (at least 1 g daily) or 10 days of prior intravenous acyclovir (15 mg/kg daily).
Trial locations and contacts
4 sites in 1 country.
United States4 sites
TheraFirst Med Ctrs Inc
Fort Lauderdale, Florida, 33308
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, 10025
Univ of Utah School of Medicine
Salt Lake City, Utah, 84132
UCSF - San Francisco Gen Hosp
San Francisco, California, 94110
About this study
Official title: A Pilot Study to Determine the Safety and Efficacy of Topically Applied SP-303T in Patients With Acquired Immunodeficiency Syndrome and Concomitant Herpes Simplex Virus (HSV) Infection Unresponsive to Acyclovir
To evaluate the safety and tolerance of topically applied SP-303T in AIDS patients. To observe the effect of this drug on herpes simplex virus lesions in patients who have failed to heal in response to oral or intravenous acyclovir therapy.
The lack of alternative treatments for herpes simplex virus infection in patients with AIDS and the development of resistance to acyclovir for patients requiring repeated treatment presents a therapeutic dilemma for physicians. SP-303T has good in vitro activity against resistant strains and offers a convenient and inexpensive means of drug administration in comparison to the use of intravenous medication.
Read the detailed description
The lack of alternative treatments for herpes simplex virus infection in patients with AIDS and the development of resistance to acyclovir for patients requiring repeated treatment presents a therapeutic dilemma for physicians. SP-303T has good in vitro activity against resistant strains and offers a convenient and inexpensive means of drug administration in comparison to the use of intravenous medication.
Patients receive 14 days (and up to 42 days) of treatment with topically applied SP-303T. SP-303T is applied directly onto herpes simplex virus lesions three times daily in a quantity sufficient to thinly cover the entire lesion, which may then be covered with an appropriate dressing, if needed. At the end of the treatment period, patients enter a follow-up period of 2 weeks.
- Conditions
- Herpes Simplex, HIV Infections
- Being tested
- Crofelemer
- Keywords
- Herpes Simplex, HIV-1, Acquired Immunodeficiency Syndrome, Antiviral Agents, Administration, Topical
- 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.
CrofelemerDrug
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)
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.
- 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)
Sponsor and investigators
- Lead sponsor
- Shaman Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002310
- Sponsor's protocol ID
- 120A
- Other IDs
- SP303T-A-01
- Status last verified
- Sep 1993
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Determine the Safety and Efficacy of Topically Applied SP-303T in Patients With Acquired Immunodeficiency Syndrome and Concomitant Herpes Simplex Virus (HSV) Infection Unresponsive to Acyclovir
- ClinicalTrials.gov ID
- NCT00002310
- Acronym / sponsor ID
- 120A
- Conditions
- Herpes Simplex, HIV Infections
- Keywords
- Herpes Simplex, HIV-1, Acquired Immunodeficiency Syndrome, Antiviral Agents, Administration, Topical
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Shaman PharmaceuticalsIndustry (pharma, biotech, devices)
- 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 evaluate the safety and tolerance of topically applied SP-303T in AIDS patients. To observe the effect of this drug on herpes simplex virus lesions in patients who have failed to heal in response to oral or intravenous acyclovir therapy.
The lack of alternative treatments for herpes simplex virus infection in patients with AIDS and the development of resistance to acyclovir for patients requiring repeated treatment presents a therapeutic dilemma for physicians. SP-303T has good in vitro activity against resistant strains and offers a convenient and inexpensive means of drug administration in comparison to the use of intravenous medication.
Detailed description
The lack of alternative treatments for herpes simplex virus infection in patients with AIDS and the development of resistance to acyclovir for patients requiring repeated treatment presents a therapeutic dilemma for physicians. SP-303T has good in vitro activity against resistant strains and offers a convenient and inexpensive means of drug administration in comparison to the use of intravenous medication.
Patients receive 14 days (and up to 42 days) of treatment with topically applied SP-303T. SP-303T is applied directly onto herpes simplex virus lesions three times daily in a quantity sufficient to thinly cover the entire lesion, which may then be covered with an appropriate dressing, if needed. At the end of the treatment period, patients enter a follow-up period of 2 weeks.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- HIV-1 infection.
- AIDS.
- Chronic mucocutaneous herpes simplex virus (HSV) infection, with one or more lesions unresponsive to oral acyclovir therapy.
- No uncontrolled infections other than HSV.
- Sufficient mental status to understand the purpose of the study and to comply with study requirements.
Key exclusion criteria (10 listed)
- Known hypersensitivity or allergy to citrus fruits, black currant berries, and rose hips.
- Any disease condition that, in the opinion of the investigator, would interfere with evaluation of the study drug, affect patient compliance, or place the patient at increased risk.
- Other unapproved investigational new drugs.
- Concurrent other therapy for herpes simplex virus (HSV) infection or medications with known activity against HSV.
- A minimum of 10 days of prior oral acyclovir (at least 1 g daily) or 10 days of prior intravenous acyclovir (15 mg/kg daily).
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 |
|---|---|---|
| Crofelemer | 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 24 Jun 2005.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crofelemer in people with Herpes Simplex and HIV Infections, run by Shaman Pharmaceuticals at 4 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 7 inclusion and 10 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 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 24 Jun 2005.