Herpes SimplexNCT00002181
Cidofovir as a Treatment for Herpes Simplex in Patients With AIDS
A study testing Cidofovir in people with Herpes Simplex and HIV Infections, run by Gilead Sciences at 15 sites in United States.
Trial summary
The purpose of this study is to see if cidofovir gel (Forvade) is safe and effective in treating herpes simplex in patients with AIDS who do not respond to acyclovir. 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?
- Cidofovir
- How many people
- Not given
- Where
- 15 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have:
- AIDS diagnosis per CDC criteria.
- At least partially external mucocutaneous HSV infection confirmed by culture of current outbreak.
- Current HSV outbreak that is unresponsive to >= 10-day course of acyclovir at 1-4 gm/day po or 15 mg/kg/day IV or in vitro resistance of HSV isolate to acyclovir demonstrated within 60 days of study.
- Signed, informed consent from parent or legal guardian for patients less than 18 years of age.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Evidence of cervical intraepithelial neoplasia class III (CIN III) on Pap smear (Pap smear required within 6 months of starting study drug).
- Concurrent Medication:
- Excluded:
- Acyclovir, valacyclovir, famciclovir, ganciclovir, foscarnet, topical trifluride, cidofovir injection or other systemic or topical drugs with anti-herpes activity.
- Required:
- >= 10 day course acyclovir at 1-4 gm/day po or 15mg/kg/day IV (not required if there is confirmed in vitro resistance to acyclovir).
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Braude Mermin Spivey MD PC
Atlanta, Georgia, 30309
Central Texas Med Foundation
Austin, Texas, 78751
Dr Nicholaos Bellos
Dallas, Texas, 75225
Dr Susan M Diamond
Dallas, Texas, 75225
ID Associates
Dallas, Texas, 75231
Heywood Memorial Hosp
Gardner, Massachusetts, 01440
Mem Med Group Inc
Long Beach, California, 90806
AIDS Healthcare Foundation Labs
Los Angeles, California, 90027
Central Florida Research Initiative
Maitland, Florida, 32751
Gouverneur Hosp
New York, New York, 10002
Sharp Mission Park / Med Group
Oceanside, California, 92054
Park Ctr for Health / Keith Vrhel
San Diego, California, 92103
Potrero Hill Med Ctr
San Francisco, California, 94107
HIV Primary Care & Consult
Santa Rosa, California, 95404
Christie Clinic / Urbana Campus
Urbana, Illinois, 61801
About this study
Official title: Open-Label Study of Cidofovir Gel for Acyclovir-Unresponsive Mucocutaneous Herpes Simplex Disease in Patients With AIDS.
The purpose of this study is to see if cidofovir gel (Forvade) is safe and effective in treating herpes simplex in patients with AIDS who do not respond to acyclovir.
Read the detailed description
Patients receive open-label treatment with cidofovir gel.
- Conditions
- Herpes Simplex, HIV Infections
- Being tested
- Cidofovir
- Keywords
- AIDS-Related Opportunistic Infections, Herpes Simplex, Acyclovir, Antiviral Agents, Gels, cidofovir
- 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.
CidofovirDrug
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.
- More trials run by Gilead SciencesThe 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)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002181
- Sponsor's protocol ID
- 218B
- Other IDs
- GS-96-307
- Status last verified
- Nov 1997
- 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
- Open-Label Study of Cidofovir Gel for Acyclovir-Unresponsive Mucocutaneous Herpes Simplex Disease in Patients With AIDS.
- ClinicalTrials.gov ID
- NCT00002181
- Acronym / sponsor ID
- 218B
- Conditions
- Herpes Simplex, HIV Infections
- Keywords
- AIDS-Related Opportunistic Infections, Herpes Simplex, Acyclovir, Antiviral Agents, Gels, cidofovir
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Gilead SciencesIndustry (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.
The purpose of this study is to see if cidofovir gel (Forvade) is safe and effective in treating herpes simplex in patients with AIDS who do not respond to acyclovir.
Detailed description
Patients receive open-label treatment with cidofovir gel.
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 (5 listed)
- AIDS diagnosis per CDC criteria.
- At least partially external mucocutaneous HSV infection confirmed by culture of current outbreak.
- Current HSV outbreak that is unresponsive to >= 10-day course of acyclovir at 1-4 gm/day po or 15 mg/kg/day IV or in vitro resistance of HSV isolate to acyclovir demonstrated within 60 days of study.
- Signed, informed consent from parent or legal guardian for patients less than 18 years of age.
Key exclusion criteria (8 listed)
- Evidence of cervical intraepithelial neoplasia class III (CIN III) on Pap smear (Pap smear required within 6 months of starting study drug).
- Acyclovir, valacyclovir, famciclovir, ganciclovir, foscarnet, topical trifluride, cidofovir injection or other systemic or topical drugs with anti-herpes activity.
- >= 10 day course acyclovir at 1-4 gm/day po or 15mg/kg/day IV (not required if there is confirmed in vitro resistance to acyclovir).
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 |
|---|---|---|
| Cidofovir | 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.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cidofovir in people with Herpes Simplex and HIV Infections, run by Gilead Sciences 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 5 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 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 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 24 Jun 2005; AzTrials last refreshed its copy on 7 Nov 2026.