HIV InfectionsPhase 1NCT00040274
A Study of DPC 817 in HIV-Infected Males
A Phase 1 study testing DPC 817 in people with HIV Infections, run by Pharmasset at 2 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate DPC 817. The safety, dosages, and how the body responds to the drug will be studied. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- DPC 817
- How many people
- 30 participants
- Where
- 2 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients may be eligible for this study if they:
- Are HIV positive
- Are male and are between 18 years of age (or the legal age of consent, whichever is older) and 55 years of age
- Are female and are between 18 years of age (or the legal age of consent, whichever is older) and 55 years of age and are not able to have children (females may participate in Part B only)
- Have no clinically significant findings on physical examination or clinical laboratory evaluations
- Have a CD4-lymphocyte count of 50 or more cells/mm3
- Are able and willing to comply with the requirements of this study
Who cannot join
- Patients will not be eligible for this study if they:
- Have an opportunistic infection characteristic of AIDS
- Are receiving any approved or experimental HIV drugs. Any previous anti-HIV treatment must be stopped at least 4 weeks before the first dose of study medication
- Are pregnant or breast-feeding
- Are enrolled in other experimental drug studies or have recieved other experimental drugs within 30 days before the first dose of study drug
- Have any disease that causes a problem with absorption of drugs
Show all 12Show fewer
- Have active hepatitis
- Have a history of pancreatitis or peripheral neuropathy
- Have received radiation therapy or chemotherapy within 30 days before the first dose of study drug
- Have received treatment with drugs that affect the immune system within 30 days before the first dose of study drug or have received an HIV immunotherapeutic vaccine
- Have taken prescription or over-the-counter products within 14 days of the first dose of study drug unless approved by the doctor
- Are unable to comply with the dosing schedule and study procedures
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
University of North Carolina Hospitals
Chapel Hill, North Carolina, 27514
About this study
Official title: A Placebo-Controlled, Dose-Escalation Study in HIV-1 Infected Subjects to Characterize the Safety, Tolerability, and Pharmacokinetics of Single Oral Doses of DPC 817
The purpose of this study is to evaluate DPC 817. The safety, dosages, and how the body responds to the drug will be studied.
Read the detailed description
The study will consist of two parts. Patients in Part A will receive a single dose of DPC 817 on two separate occasions and a placebo (a solution or tablet without the drug) on one occasion. Patients in Part B will receive two separate doses of DPC 817. Patients will be admitted to the clinical study unit the day before dosing (Day -1) and remain there for at least 48 hours after taking the study drug. Patients will return to the clinical study unit on Day 8 and Day 28 following the dose in the last treatment period. During the study there will be medical and medication histories taken, physical examinations, vital sign measurements, and routine clinical laboratory tests.
- Conditions
- HIV Infections
- Being tested
- DPC 817
- Keywords
- HIV, Phase I
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DPC 817Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2002 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Pharmasset
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00040274
- Sponsor's protocol ID
- DPC 817-201
- Status last verified
- Jul 2005
- First submitted
- 24 Jun 2002
- Last updated
- 19 Jul 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-Controlled, Dose-Escalation Study in HIV-1 Infected Subjects to Characterize the Safety, Tolerability, and Pharmacokinetics of Single Oral Doses of DPC 817
- ClinicalTrials.gov ID
- NCT00040274
- Acronym / sponsor ID
- DPC 817-201
- Conditions
- HIV Infections
- Keywords
- HIV, Phase I
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- PharmassetIndustry (pharma, biotech, devices)
- First posted
- 25 Jun 2002 (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 evaluate DPC 817. The safety, dosages, and how the body responds to the drug will be studied.
Detailed description
The study will consist of two parts. Patients in Part A will receive a single dose of DPC 817 on two separate occasions and a placebo (a solution or tablet without the drug) on one occasion. Patients in Part B will receive two separate doses of DPC 817. Patients will be admitted to the clinical study unit the day before dosing (Day -1) and remain there for at least 48 hours after taking the study drug. Patients will return to the clinical study unit on Day 8 and Day 28 following the dose in the last treatment period. During the study there will be medical and medication histories taken, physical examinations, vital sign measurements, and routine clinical laboratory tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Are HIV positive
- Are male and are between 18 years of age (or the legal age of consent, whichever is older) and 55 years of age
- Are female and are between 18 years of age (or the legal age of consent, whichever is older) and 55 years of age and are not able to have children (females may participate in Part B only)
- Have no clinically significant findings on physical examination or clinical laboratory evaluations
- Have a CD4-lymphocyte count of 50 or more cells/mm3
Key exclusion criteria (12 listed)
- Have an opportunistic infection characteristic of AIDS
- Are receiving any approved or experimental HIV drugs. Any previous anti-HIV treatment must be stopped at least 4 weeks before the first dose of study medication
- Are pregnant or breast-feeding
- Are enrolled in other experimental drug studies or have recieved other experimental drugs within 30 days before the first dose of study drug
- Have any disease that causes a problem with absorption of drugs
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 |
|---|---|---|
| DPC 817 | 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 19 Jul 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.
2 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 DPC 817 in people with HIV Infections, run by Pharmasset at 2 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 7 inclusion and 12 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 19 Jul 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Germany. 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?
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 19 Jul 2005.