HIV InfectionsPhase 1NCT00002164
Phase I Study of Safety, Tolerability, and Pharmacokinetics of Viracept in HIV-1 Infected Children and Exposed Infants
A Phase 1 study testing Nelfinavir mesylate in people with HIV Infections, run by Agouron Pharmaceuticals at 1 site in United States.
Trial summary
To evaluate the single dose pharmacokinetic profile of Viracept pediatric powder formulation administered to HIV infected or exposed children and infants (0 to 13 years of age). An evaluation of the relative bioavailability of the pediatric powder formulation vs. Read more about this study
- Who is it for?
- Ages 1 day to 13 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Nelfinavir mesylate
- How many people
- 24 participants
- Where
- 1 siteUnited States
- 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 1 day to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Concurrent Medication:
- Allowed:
- Administration of Pneumocystis carinii pneumonia prophylaxis according to CDC guidelines will be permitted.
- Patients must have:
- For children >= 3 months to 13 years of age:
- HIV infection. For children <3 months of age:
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- HIV infection or exposure.
- Newborns must have birth weight >= 2500 gm.
- Absence at screen of any serious or unstable medical conditions.
- Parent or guardian able to give written informed consent and willing to comply with study requirements.
Who cannot join
- Co-existing Condition:
- Patients with any of the following symptoms or conditions are excluded:
- Children with HIV associated malignancy requiring chemotherapy.
- Children with clinical or laboratory assessments greater than Grade 1 in the Toxicity Table at the time of the screening.
- Concurrent Medication:
- Excluded:
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- Chemotherapy.
- Prior Medication:
- Excluded:
- Protease inhibitors.
- NOTE:
- Patients who have taken investigational agents, immunomodulators, HIV-1 vaccines, glucocorticoids or unconventional therapies within one month prior to the day 0 of the study must be evaluated to determine the impact of these treatments on the study. Patients may be included or excluded on a case to case basis.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA School of Medicine / Dept of Pediatrics
Los Angeles, California, 90024
About this study
To evaluate the single dose pharmacokinetic profile of Viracept pediatric powder formulation administered to HIV infected or exposed children and infants (0 to 13 years of age). An evaluation of the relative bioavailability of the pediatric powder formulation vs. a standard tablet formulation in older children (7 to 13 years of age) will also be conducted.
Read the detailed description
This is a study of the safety, tolerability and pharmacokinetics of a Viracept pediatric powder formulation with milk or formula. First a single dose will be administered. After the patient population is divided into 4 groups by age, an optimal dose will be determined for each group. This optimal dose will be given 3 times a day for a 6 week primary observation period, plus an optional 6 month extension.
NOTE: During the single dose portion of this study, patients may be untreated or may continue treatment with their current nucleoside antiretroviral therapy. During multiple dose administration of Viracept, antiretroviral therapy will be intensified by either adding or modifying therapy. Antiretroviral therapies will be limited to those currently licensed including zidovudine, lamivudine, stavudine, didanosine or zalcitabine.
- Conditions
- HIV Infections
- Being tested
- Nelfinavir mesylate
- Keywords
- Biological Availability, HIV Protease Inhibitors, Dosage Forms, Nelfinavir
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nelfinavir mesylateDrug
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 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
- Enrolment
- 24 participants
Sponsor and investigators
- Lead sponsor
- Agouron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002164
- Sponsor's protocol ID
- 259E
- Other IDs
- AG 1343-524
- Status last verified
- May 1999
- 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
- Phase I Study of Safety, Tolerability, and Pharmacokinetics of Viracept in HIV-1 Infected Children and Exposed Infants
- ClinicalTrials.gov ID
- NCT00002164
- Acronym / sponsor ID
- 259E
- Conditions
- HIV Infections
- Keywords
- Biological Availability, HIV Protease Inhibitors, Dosage Forms, Nelfinavir
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- Agouron 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 single dose pharmacokinetic profile of Viracept pediatric powder formulation administered to HIV infected or exposed children and infants (0 to 13 years of age). An evaluation of the relative bioavailability of the pediatric powder formulation vs. a standard tablet formulation in older children (7 to 13 years of age) will also be conducted.
Detailed description
This is a study of the safety, tolerability and pharmacokinetics of a Viracept pediatric powder formulation with milk or formula. First a single dose will be administered. After the patient population is divided into 4 groups by age, an optimal dose will be determined for each group. This optimal dose will be given 3 times a day for a 6 week primary observation period, plus an optional 6 month extension.
NOTE: During the single dose portion of this study, patients may be untreated or may continue treatment with their current nucleoside antiretroviral therapy. During multiple dose administration of Viracept, antiretroviral therapy will be intensified by either adding or modifying therapy. Antiretroviral therapies will be limited to those currently licensed including zidovudine, lamivudine, stavudine, didanosine or zalcitabine.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 1 day to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Administration of Pneumocystis carinii pneumonia prophylaxis according to CDC guidelines will be permitted.
- For children >= 3 months to 13 years of age:
- HIV infection. For children <3 months of age:
- HIV infection or exposure.
- Newborns must have birth weight >= 2500 gm.
Key exclusion criteria (12 listed)
- Children with HIV associated malignancy requiring chemotherapy.
- Children with clinical or laboratory assessments greater than Grade 1 in the Toxicity Table at the time of the screening.
- Chemotherapy.
- Protease inhibitors.
- Patients who have taken investigational agents, immunomodulators, HIV-1 vaccines, glucocorticoids or unconventional therapies within one month prior to the day 0 of the study must be evaluated to determine the impact of these treatments on the study. Patients may be included or excluded on a case to case basis.
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 |
|---|---|---|
| Nelfinavir mesylate | 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nelfinavir mesylate in people with HIV Infections, run by Agouron Pharmaceuticals 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 10 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 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.
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 24 Jun 2005.