Herpes SimplexPhase 1NCT00002116
A Phase I/II Study of the Safety and Efficacy of Topical 1-(S)-(3-Hydroxy-2-Phosphonylmethoxypropyl)Cytosine Dihydrate (Cidofovir; HPMPC) in the Treatment of Refractory Mucocutaneous Herpes Simplex Disease in Patients With AIDS
A Phase 1 study testing Cidofovir in people with Herpes Simplex and HIV Infections, run by Gilead Sciences at 9 sites in 2 countries.
Trial summary
To evaluate the safety and tolerance of topical cidofovir (HPMPC) therapy for refractory mucocutaneous herpes simplex virus disease in AIDS patients. To determine whether topical HPMPC therapy can induce re-epithelialization and healing of refractory mucocutaneous herpes simplex virus disease in AIDS 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?
- Cidofovir
- How many people
- 30 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Start not givento not given
- Phase
- Phase 1
- 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:
- Allowed:
- Antiretroviral therapy with AZT, ddI, ddC, or d4T.
- Oral trimethoprim/sulfamethoxazole.
- Dapsone.
- Atovaquone.
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- Fluconazole.
- Rifabutin.
- Clarithromycin.
- Patients must have:
- HIV seropositivity.
- Mucocutaneous herpes simplex virus (HSV) infection confirmed by previous viral culture and persisting without improvement despite at least 10 days of acyclovir at a minimum dose of 1 g/day (oral) or 15 mg/kg/day (intravenous).
- Measurable lesions.
- Consent of parent or guardian if less than 18 years of age.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Active medical problems sufficient to hinder study compliance or assessment of treatment effect.
- Concurrent Medication:
- Excluded:
- Acyclovir.
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- Immunomodulators (such as corticosteroids or interferons).
- Lymphocyte replacement therapy.
- Biologic response modifiers.
- Ganciclovir.
- Foscarnet.
- Vidarabine.
- Topical trifluridine.
- Other investigational drugs (except d4T).
- Amphotericin.
- Intravenous therapy for PCP.
- Chemotherapeutic agents.
- Prior Medication:
- Excluded within 14 days prior to study entry:
- Immunomodulators (such as corticosteroids or interferons).
- Lymphocyte replacement therapy.
- Biologic response modifiers.
- Ganciclovir.
- Foscarnet.
- Vidarabine.
- Topical trifluridine.
- Other investigational drugs with potential anti-HSV activity.
- Amphotericin.
- Intravenous therapy for PCP.
- Excluded within 4 weeks prior to study entry:
- Chemotherapeutic agents.
- Required:
- At least 10 days of prior acyclovir at a minimum dose of 1 g/day (oral) or 15 mg/kg/day (intravenous).
- Substance abuse.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States8 sites
Johns Hopkins Hosp
Baltimore, Maryland, 21205
Univ of North Carolina Hosps
Chapel Hill, North Carolina, 27599
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
Park Plaza Hosp
Houston, Texas, 77004
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
UCSF - San Francisco Gen Hosp
San Francisco, California, 94110
Mount Zion Med Ctr / UCSF
San Francisco, California, 94115
Univ of Washington / Viral Disease Clinic
Seattle, Washington, 98122
About this study
To evaluate the safety and tolerance of topical cidofovir (HPMPC) therapy for refractory mucocutaneous herpes simplex virus disease in AIDS patients. To determine whether topical HPMPC therapy can induce re-epithelialization and healing of refractory mucocutaneous herpes simplex virus disease in AIDS patients. To evaluate the virologic effects of topical HPMPC therapy on herpes simplex virus shedding from refractory lesions.
Read the detailed description
Patients are randomized to receive topical therapy with placebo (vehicle alone) or HPMPC at either 0.3 or 1.0 percent once daily for 5 days. Patients are assessed to day 15; those with no significant toxicity are eligible to receive open-label topical HPMPC for up to 6 months.
- Conditions
- Herpes Simplex, HIV Infections
- Being tested
- Cidofovir
- Keywords
- Herpes Simplex, Acquired Immunodeficiency Syndrome, Antiviral Agents, cidofovir
- 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.
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.
- Publications (1)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 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 1
- Primary purpose
- Treatment
- Masking
- Double blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002116
- Sponsor's protocol ID
- 218A
- Other IDs
- GS-93-301
- Status last verified
- Dec 1995
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Acyclovir-resistant herpes: expanded access available for cidofovir gel (Forvade). AIDS Treat News. 1997 Feb 7;(No 264):5.
PubMed 11364104
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 Phase I/II Study of the Safety and Efficacy of Topical 1-(S)-(3-Hydroxy-2-Phosphonylmethoxypropyl)Cytosine Dihydrate (Cidofovir; HPMPC) in the Treatment of Refractory Mucocutaneous Herpes Simplex Disease in Patients With AIDS
- ClinicalTrials.gov ID
- NCT00002116
- Acronym / sponsor ID
- 218A
- Conditions
- Herpes Simplex, HIV Infections
- Keywords
- Herpes Simplex, Acquired Immunodeficiency Syndrome, Antiviral Agents, cidofovir
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- 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.
To evaluate the safety and tolerance of topical cidofovir (HPMPC) therapy for refractory mucocutaneous herpes simplex virus disease in AIDS patients. To determine whether topical HPMPC therapy can induce re-epithelialization and healing of refractory mucocutaneous herpes simplex virus disease in AIDS patients. To evaluate the virologic effects of topical HPMPC therapy on herpes simplex virus shedding from refractory lesions.
Detailed description
Patients are randomized to receive topical therapy with placebo (vehicle alone) or HPMPC at either 0.3 or 1.0 percent once daily for 5 days. Patients are assessed to day 15; those with no significant toxicity are eligible to receive open-label topical HPMPC for up to 6 months.
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)
- Antiretroviral therapy with AZT, ddI, ddC, or d4T.
- Oral trimethoprim/sulfamethoxazole.
- Dapsone.
- Atovaquone.
- Fluconazole.
Key exclusion criteria (34 listed)
- Active medical problems sufficient to hinder study compliance or assessment of treatment effect.
- Acyclovir.
- Immunomodulators (such as corticosteroids or interferons).
- Lymphocyte replacement therapy.
- Biologic response modifiers.
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.
- Background: PubMed 11364104Acyclovir-resistant herpes: expanded access available for cidofovir gel (Forvade). AIDS Treat News. 1997 Feb 7;(No 264):5.
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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.
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cidofovir in people with Herpes Simplex and HIV Infections, run by Gilead Sciences at 9 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 14 inclusion and 34 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 9 sites in United States, Canada. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 NCT00002116, which also lists 1 linked publication.
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.