Candidiasis, EsophagealNCT00005921
A Study of the Side Effects of L-743,872 in Men With Candidal Esophagitis
A study testing L-743,872 in people with Candidiasis, Esophageal and HIV Infections, run by Merck Sharp & Dohme LLC at 1 site in United States.
Trial summary
The purpose of this study is to see if it is safe to give L-743,872 to men with candidal esophagitis, an AIDS-related yeast infection in the esophagus. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Candidiasis, Esophageal, HIV Infections
- What is being tested?
- L-743,872
- How many people
- 18 participants
- Where
- 1 siteUnited 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 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- You may be eligible for this study if you:
- Are an 18- to 65-year-old man with candidal esophagitis.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open, Serial-Panel, Multiple-Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of L-743,872 in Patients With Candida Esophagitis
The purpose of this study is to see if it is safe to give L-743,872 to men with candidal esophagitis, an AIDS-related yeast infection in the esophagus.
Read the detailed description
In this open-label study, patients receive intravenous L-743,872 every 24 hours at one of three dose levels for 14 days. Post-study safety evaluations continue for 4 weeks after the final dose. Pharmacokinetics and safety measurements are taken throughout the 6-week study.
- Conditions
- Candidiasis, Esophageal, HIV Infections
- Being tested
- L-743,872
- Keywords
- Dose-Response Relationship, Drug, Antifungal Agents, Candidiasis, Esophageal Diseases, MK 0991
- Medical subject headings
- Candidiasis, HIV Infections, Esophageal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-743,872Drug
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 Candidiasis, EsophagealStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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
- 18 participants
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005921
- Sponsor's protocol ID
- 267A
- Other IDs
- 007-00
- Status last verified
- Jun 2000
- First submitted
- 19 Jun 2000
- 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
- An Open, Serial-Panel, Multiple-Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of L-743,872 in Patients With Candida Esophagitis
- ClinicalTrials.gov ID
- NCT00005921
- Acronym / sponsor ID
- 267A
- Conditions
- Candidiasis, Esophageal, HIV Infections
- Keywords
- Dose-Response Relationship, Drug, Antifungal Agents, Candidiasis, Esophageal Diseases, MK 0991
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (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 it is safe to give L-743,872 to men with candidal esophagitis, an AIDS-related yeast infection in the esophagus.
Detailed description
In this open-label study, patients receive intravenous L-743,872 every 24 hours at one of three dose levels for 14 days. Post-study safety evaluations continue for 4 weeks after the final dose. Pharmacokinetics and safety measurements are taken throughout the 6-week study.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Are an 18- to 65-year-old man with candidal esophagitis.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| L-743,872 | 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.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-743,872 in people with Candidiasis, Esophageal and HIV Infections, run by Merck Sharp & Dohme LLC at 1 site 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 2 inclusion and 0 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 1 site 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.