Herpes SimplexNCT00002186
Double-Blind Placebo-Controlled Study Comparing the Combination of 15% SP-303 Gel With Acyclovir Versus Acyclovir Alone for the Treatment of Recurrent Herpes Simplex Virus (HSV) Infections in Subjects With Acquired Immunodeficiency Syndrome (AIDS)
A study testing Crofelemer and Acyclovir in people with Herpes Simplex and HIV Infections, run by Shaman Pharmaceuticals at 34 sites in 2 countries.
Trial summary
To evaluate the safety of topically applied SP-303 gel and to compare the efficacy of SP-303 gel in combination with acyclovir, relative to acyclovir alone, for the treatment of recurrent Herpes Simplex Virus (HSV) 1 and 2 infections, affecting the genital, perianal and neighboring areas, in patients with AIDS. 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 and Acyclovir
- How many people
- 400 participants
- Where
- 34 sitesin 2 countries
- 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:
- AIDS, according to the CDC criteria.
- Documented recurrent (at least 1 prior episode) perineal (genital, perianal and neighboring areas) mucocutaneous herpes simplex virus (HSV) types 1 or 2 infection in the active phase.
- Duration of current episode of recurrent HSV lesions of 3 days or less.
- Ability to read and write, must be intellectually competent, and able to understand the purposes and risks of the study.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms and conditions are excluded:
- Active internal anal or rectal herpes.
- Inability to comply with protocol.
- Impaired renal function.
- Patients with the following prior conditions are excluded:
Show all 15Show fewer
- Prior episode of recurrent genital herpes infection with documented clinical failure of acyclovir as a treatment regimen.
- Uncompensated hepatic, cardiac, or renal failure within 1 month of the study.
- History of hypersensitivity to acyclovir.
- Previous enrollment in this study.
- 1. Treatment with another medication (topical, oral, or intravenous) with known anti-HSV activity within the past 5 days.
- Systemic immunomodulatory therapy within 30 days prior to study.
- Previous treatment with SP-303.
- Required:
- Unchanged antiretroviral therapy for the 2 weeks prior to study.
Trial locations and contacts
34 sites in 2 countries.
34 sites in 2 countries
United States32 sites
IDC Research Initiative
Altamonte Springs, Florida, 32701
Dr Robert Holman
Arlington, Virginia, 22205
Austin Infectious Disease Consultants
Austin, Texas, 78705
Johns Hopkins Univ / Division of Infectious Disease
Baltimore, Maryland, 21205
Saint Agnes Healthcare / Dept of Surgery
Baltimore, Maryland, 21229
Sorra Research Ctr Inc / Med Forum
Birmingham, Alabama, 35203
Massachusetts Gen Hosp - Warren 505
Boston, Massachusetts, 02114
Veterans Affairs Med Ctr of North Chicago
Chicago, Illinois, 60064
N Texas Ctr for AIDS & Clin Rsch
Dallas, Texas, 75219
Gary Richmond MD
Fort Lauderdale, Florida, 33316
Dr Robert Schwartz
Fort Myers, Florida, 33901
Division of Infectious Diseases / Univ of Texas - Houston
Houston, Texas, 77030
Dermatology SVC - VAMC
Long Beach, California, 90822
King - Drew Med Ctr / Dept of Dermatology
Los Angeles, California, 90059
Medicine / Infectious Diseases
Minneapolis, Minnesota, 55455
AIDS Ctr / Saint Vincents Hosp and Med Ctr
New York, New York, 10011
New York Univ Med Ctr
New York, New York, 10016
Mount Sinai Med Ctr
New York, New York, 10029
Columbia Presbyterian Med Ctr
New York, New York, 10032
Summit Med Ctr / Adult Immunology Clinic
Oakland, California, 94609
ViRx Inc
Palm Springs, California, 92262
Paddington Testing Co Inc
Philadelphia, Pennsylvania, 19103
ViRx Inc
San Francisco, California, 94109
Conant Med Ctr
San Francisco, California, 94117
Hill Top Research Ltd
Scottsdale, Arizona, 85251
Novum Inc
Seattle, Washington, 98122
Univ of Washington Virology Research Clinic
Seattle, Washington, 98122
Olive View Med Ctr
Sylmar, California, 91342
Infectious Disease Research Institute Inc
Tampa, Florida, 33614
Arizona Clinical Research Ctr Inc
Tucson, Arizona, 85712
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, 32960
Novum Inc
Washington D.C., District of Columbia, 20037
Puerto Rico2 sites
Hosp Regional de Ponce - Area Vieja
Ponce, 00731
San Juan AIDS Program
Santurce, 00908
About this study
To evaluate the safety of topically applied SP-303 gel and to compare the efficacy of SP-303 gel in combination with acyclovir, relative to acyclovir alone, for the treatment of recurrent Herpes Simplex Virus (HSV) 1 and 2 infections, affecting the genital, perianal and neighboring areas, in patients with AIDS.
Read the detailed description
This trial is a double-blind, multicenter, placebo-controlled clinical trial. Participants are randomized to topical 15% SP-303 gel and oral acyclovir or to matching topical placebo gel and oral acyclovir. At presentation, patients are stratified by total lesion area within each treatment group. SP-303 or matching placebo is topically applied three times a day until all lesions are reepithelialized or for 14 days, whichever occurs earlier. Acyclovir is administered by mouth each day, three times a day, until all lesions are reepithelialized or for 14 days, whichever occurs earlier. Patients are evaluated for lesion healing and adverse events 3 times per week during the treatment period. The primary efficacy endpoint will be complete lesion healing and the primary analysis will be time to complete healing.
- Conditions
- Herpes Simplex, HIV Infections
- Being tested
- Crofelemer, Acyclovir
- Keywords
- AIDS-Related Opportunistic Infections, Herpes Simplex, Drug Therapy, Combination, Acyclovir, Antiviral Agents, Gels, SP 303
- Medical subject headings
- Herpes Simplex, HIV Infections, AIDS-Related Opportunistic Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CrofelemerDrug
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)
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
- Double blind
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- Shaman Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002186
- Sponsor's protocol ID
- 270A
- Other IDs
- 96-867-DE
- Status last verified
- Feb 1998
- 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
- Double-Blind Placebo-Controlled Study Comparing the Combination of 15% SP-303 Gel With Acyclovir Versus Acyclovir Alone for the Treatment of Recurrent Herpes Simplex Virus (HSV) Infections in Subjects With Acquired Immunodeficiency Syndrome (AIDS)
- ClinicalTrials.gov ID
- NCT00002186
- Acronym / sponsor ID
- 270A
- Conditions
- Herpes Simplex, HIV Infections
- Keywords
- AIDS-Related Opportunistic Infections, Herpes Simplex, Drug Therapy, Combination, Acyclovir, Antiviral Agents, Gels, SP 303
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants
- 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 of topically applied SP-303 gel and to compare the efficacy of SP-303 gel in combination with acyclovir, relative to acyclovir alone, for the treatment of recurrent Herpes Simplex Virus (HSV) 1 and 2 infections, affecting the genital, perianal and neighboring areas, in patients with AIDS.
Detailed description
This trial is a double-blind, multicenter, placebo-controlled clinical trial. Participants are randomized to topical 15% SP-303 gel and oral acyclovir or to matching topical placebo gel and oral acyclovir. At presentation, patients are stratified by total lesion area within each treatment group. SP-303 or matching placebo is topically applied three times a day until all lesions are reepithelialized or for 14 days, whichever occurs earlier. Acyclovir is administered by mouth each day, three times a day, until all lesions are reepithelialized or for 14 days, whichever occurs earlier. Patients are evaluated for lesion healing and adverse events 3 times per week during the treatment period. The primary efficacy endpoint will be complete lesion healing and the primary analysis will be time to complete healing.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- AIDS, according to the CDC criteria.
- Documented recurrent (at least 1 prior episode) perineal (genital, perianal and neighboring areas) mucocutaneous herpes simplex virus (HSV) types 1 or 2 infection in the active phase.
- Duration of current episode of recurrent HSV lesions of 3 days or less.
- Ability to read and write, must be intellectually competent, and able to understand the purposes and risks of the study.
Key exclusion criteria (15 listed)
- Active internal anal or rectal herpes.
- Inability to comply with protocol.
- Impaired renal function.
- Prior episode of recurrent genital herpes infection with documented clinical failure of acyclovir as a treatment regimen.
- Uncompensated hepatic, cardiac, or renal failure within 1 month of the study.
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 | – |
| 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 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.
34 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crofelemer and Acyclovir in people with Herpes Simplex and HIV Infections, run by Shaman Pharmaceuticals at 34 sites in 2 countries.
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 5 inclusion and 15 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 34 sites in United States, Puerto Rico. 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.