HIV InfectionsPhase 1NCT00002351
A Study of L-735,524 in HIV-Positive Children and Adolescents
A Phase 1 study testing Indinavir sulfate in people with HIV Infections, run by Merck Sharp & Dohme LLC at 1 site in United States.
Trial summary
To evaluate the safety, tolerability, and plasma concentration profiles of indinavir sulfate ( MK-639; Crixivan ) in HIV-seropositive older children and adolescents. To compare the plasma concentration profile after the initial dose with data from a historical group of adults. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Indinavir sulfate
- How many people
- 12 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients must have:
- HIV positivity.
- No active opportunistic infection within the past 30 days, other than superficial candidiasis of the oral cavity or vagina.
- Body surface area at least 1.0 sqm.
- Consent of parent or guardian.
- Prior Medication:
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- Allowed:
- Aerosolized pentamidine.
- Topical antifungals.
- TMP / SMX.
- AZT.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Significant hepatic disease including HBsAg or hepatitis C positivity.
- Significant neurologic disease such as loss of intellectual ability, motor deficits, or seizure disorder.
- Significant cardiac disease including dysrhythmia or cardiomyopathy.
- Significant medical condition or laboratory abnormality that may pose additional risk to patient on study or confound the results.
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- Has a social situation that may interfere with study participation.
- Concurrent Medication:
- Excluded:
- Oral contraceptives.
- Patients with the following prior conditions are excluded:
- History of serious allergic drug reactions.
- History of significant cardiac disease.
- Participation on another clinical trial within the past 4 weeks.
- Donated blood within the past 4 weeks.
- Prior Medication:
- Excluded within the past 4 weeks:
- Hematopoietic growth factors.
- Excluded within the past 2 weeks:
- Antiretroviral agent other than zidovudine.
- Oral contraceptives.
- Prophylaxis for opportunistic infections, other than aerosolized pentamidine, topical antifungals, and TMP/SMX.
- Any other medication unless approved by Merck clinical monitor. Current illicit drug use.
Trial locations and contacts
1 site in 1 country.
United States1 site
Merck & Co Inc
Whitehouse Station, New Jersey, 088890100
About this study
Official title: An Open-Labeled, Multiple Dose, Multicenter Study to Investigate the Safety, Tolerability, and Plasma Concentration Profile of L-735,524 Capsules in HIV-Seropositive Older Children and Adolescent Patients
To evaluate the safety, tolerability, and plasma concentration profiles of indinavir sulfate ( MK-639; Crixivan ) in HIV-seropositive older children and adolescents. To compare the plasma concentration profile after the initial dose with data from a historical group of adults. To obtain preliminary data on antiviral activity of MK-639.
Read the detailed description
Patients receive MK-639 for 14 and one-third days. Repeat plasma samples are collected up to 8 hours following the first and last dose. Urine samples are collected on days 1 and 5.
- Conditions
- HIV Infections
- Being tested
- Indinavir sulfate
- Keywords
- Acquired Immunodeficiency Syndrome, AIDS-Related Complex, HIV Protease Inhibitors, Indinavir
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indinavir sulfateDrug
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 HIV InfectionsStudies 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 1
- Primary purpose
- Treatment
- Enrolment
- 12 participants
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002351
- Sponsor's protocol ID
- 246A
- Other IDs
- 026-01
- Status last verified
- Oct 1995
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Mueller BU, Sleasman J, Nelson RP Jr, Smith S, Deutsch PJ, Ju W, Steinberg SM, Balis FM, Jarosinski PF, Brouwers P, Mistry G, Winchell G, Zwerski S, Sei S, Wood LV, Zeichner S, Pizzo PA. A phase I/II study of the protease inhibitor indinavir in children with HIV infection. Pediatrics. 1998 Jul;102(1 Pt 1):101-9. doi: 10.1542/peds.102.1.101.
PubMed 9651421
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-Labeled, Multiple Dose, Multicenter Study to Investigate the Safety, Tolerability, and Plasma Concentration Profile of L-735,524 Capsules in HIV-Seropositive Older Children and Adolescent Patients
- ClinicalTrials.gov ID
- NCT00002351
- Acronym / sponsor ID
- 246A
- Conditions
- HIV Infections
- Keywords
- Acquired Immunodeficiency Syndrome, AIDS-Related Complex, HIV Protease Inhibitors, Indinavir
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 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.
To evaluate the safety, tolerability, and plasma concentration profiles of indinavir sulfate ( MK-639; Crixivan ) in HIV-seropositive older children and adolescents. To compare the plasma concentration profile after the initial dose with data from a historical group of adults. To obtain preliminary data on antiviral activity of MK-639.
Detailed description
Patients receive MK-639 for 14 and one-third days. Repeat plasma samples are collected up to 8 hours following the first and last dose. Urine samples are collected on days 1 and 5.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- HIV positivity.
- No active opportunistic infection within the past 30 days, other than superficial candidiasis of the oral cavity or vagina.
- Body surface area at least 1.0 sqm.
- Consent of parent or guardian.
- Aerosolized pentamidine.
Key exclusion criteria (23 listed)
- Significant hepatic disease including HBsAg or hepatitis C positivity.
- Significant neurologic disease such as loss of intellectual ability, motor deficits, or seizure disorder.
- Significant cardiac disease including dysrhythmia or cardiomyopathy.
- Significant medical condition or laboratory abnormality that may pose additional risk to patient on study or confound the results.
- Has a social situation that may interfere with study participation.
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 |
|---|---|---|
| Indinavir sulfate | 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 9651421Mueller BU, Sleasman J, Nelson RP Jr, Smith S, Deutsch PJ, Ju W, Steinberg SM, Balis FM, Jarosinski PF, Brouwers P, Mistry G, Winchell G, Zwerski S, Sei S, Wood LV, Zeichner S, Pizzo PA. A phase I/II study of the protease inhibitor indinavir in children with HIV infection. Pediatrics. 1998 Jul;102(1 Pt 1):101-9. doi: 10.1542/peds.102.1.101.
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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 Indinavir sulfate in people with 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 11 inclusion and 23 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?
On the ClinicalTrials.gov record for NCT00002351, 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.