HIV InfectionsNCT00000634
A Pilot Pharmacokinetic Phase I Evaluation of BI-RG-587 in HIV-Infected Children
A study testing Nevirapine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
To generate initial information on the pharmacokinetics (blood levels) and dose proportionality of nevirapine (BI-RG-587) plasma levels in HIV-infected children; to assess the safety and tolerance of single rising oral doses of nevirapine in HIV-infected children; and to confirm that the single doses that achieve… Read more about this study
- Who is it for?
- Ages 2 months to 13 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Nevirapine
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Jun 1995
- 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 2 months to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Concurrent Medication:
- Allowed:
- Intravenous gammaglobulin. Pneumocystis prophylaxis according to published guidelines.
- Patients must have the following:
- HIV infection.
- Parent or guardian must be available to give written informed consent.
Who cannot join
- Concurrent Medication:
- Excluded:
- Zidovudine (AZT).
- Steroid dependency.
- Excluded within 1 hour before and 4 hours after study drug administration:
- Drugs that might interfere with the absorption of study drug (H2 blockers, antacids, carafate, cholestyramine).
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- Benzodiazepines.
- Alcohol-containing substances.
- Concurrent Treatment:
- Excluded:
- Requiring supplemental oxygen.
- Patients with the following are excluded:
- Active opportunistic or serious bacterial infection.
- Lymphoid interstitial pneumonitis (LIP) and steroid dependent or requiring supplemental oxygen or have a pretreatment pa02 < 70 mm Hg.
- Pre-existing malignancies.
- Prior Medication:
- Excluded:
- Zidovudine (AZT) within 7 days prior to administration of study drug.
- Excluded for at least 4 weeks prior to drug administration:
- Other approved or investigational antiretroviral agents. All other investigational agents. Biologic response modifiers (e.g., interferon) or immunomodulators. Immunosuppressive agents (including glucocorticoids). Coumadin and other anticoagulant medications.
- Prior Treatment:
- Excluded:
- Red blood cell transfusion within 4 weeks of study entry.
- Patients may not have the following:
- Opportunistic or serious bacterial infection.
- Zidovudine (AZT) > 7 days prior to administration of study drug.
- Active alcohol or drug abuse.
Trial locations and contacts
1 site in 1 country.
United States1 site
Univ of Massachusetts Med Ctr / Biotech II
Worcester, Massachusetts, 01605
About this study
To generate initial information on the pharmacokinetics (blood levels) and dose proportionality of nevirapine (BI-RG-587) plasma levels in HIV-infected children; to assess the safety and tolerance of single rising oral doses of nevirapine in HIV-infected children; and to confirm that the single doses that achieve certain plasma levels in adults achieve similar levels in HIV-infected children.
Test tube studies have shown that nevirapine (BI-RG-587) inhibits replication (reproduction) of HIV. Nevirapine works with zidovudine (AZT) and is active against strains of the virus that are resistant to AZT. Studies of the drug in HIV-infected adults showed no serious adverse effects.
Read the detailed description
Test tube studies have shown that nevirapine (BI-RG-587) inhibits replication (reproduction) of HIV. Nevirapine works with zidovudine (AZT) and is active against strains of the virus that are resistant to AZT. Studies of the drug in HIV-infected adults showed no serious adverse effects.
Two doses, given by mouth, are evaluated: Three patients receive the lower dose, and 7 days after the third patient receives the lower dose, three additional patients receive the higher dose. After dosing, blood is drawn at 1, 2, 4, 8, 24, 48, 96, 168 hours to measure blood levels of the drug.
- Conditions
- HIV Infections
- Being tested
- Nevirapine
- Keywords
- Benzodiazepines, Drug Evaluation, Drugs, Investigational, Acquired Immunodeficiency Syndrome, Antiviral Agents
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NevirapineDrug
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)
- Primary completionJun 1995
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 National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Enrolment
- 6 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000634
- Sponsor's protocol ID
- ACTG 165
- Other IDs
- 00853
- Status last verified
- Feb 2011
- First submitted
- 2 Nov 1999
- Last updated
- 1 Mar 2011
- Results posted
- No
Publications
Luzuriaga K, Bryson Y, McSherry G, Robinson J, Stechenberg B, Scott G, Lamson M, Cort S, Sullivan JL. Pharmacokinetics, safety, and activity of nevirapine in human immunodeficiency virus type 1-infected children. J Infect Dis. 1996 Oct;174(4):713-21. doi: 10.1093/infdis/174.4.713.
PubMed 8843207
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Pharmacokinetic Phase I Evaluation of BI-RG-587 in HIV-Infected Children
- ClinicalTrials.gov ID
- NCT00000634
- Acronym / sponsor ID
- ACTG 165
- Conditions
- HIV Infections
- Keywords
- Benzodiazepines, Drug Evaluation, Drugs, Investigational, Acquired Immunodeficiency Syndrome, Antiviral Agents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Boehringer Ingelheim
- Primary completion
- Jun 1995 (actual)
- 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 generate initial information on the pharmacokinetics (blood levels) and dose proportionality of nevirapine (BI-RG-587) plasma levels in HIV-infected children; to assess the safety and tolerance of single rising oral doses of nevirapine in HIV-infected children; and to confirm that the single doses that achieve certain plasma levels in adults achieve similar levels in HIV-infected children.
Test tube studies have shown that nevirapine (BI-RG-587) inhibits replication (reproduction) of HIV. Nevirapine works with zidovudine (AZT) and is active against strains of the virus that are resistant to AZT. Studies of the drug in HIV-infected adults showed no serious adverse effects.
Detailed description
Test tube studies have shown that nevirapine (BI-RG-587) inhibits replication (reproduction) of HIV. Nevirapine works with zidovudine (AZT) and is active against strains of the virus that are resistant to AZT. Studies of the drug in HIV-infected adults showed no serious adverse effects.
Two doses, given by mouth, are evaluated: Three patients receive the lower dose, and 7 days after the third patient receives the lower dose, three additional patients receive the higher dose. After dosing, blood is drawn at 1, 2, 4, 8, 24, 48, 96, 168 hours to measure blood levels of the drug.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 2 months to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Intravenous gammaglobulin. Pneumocystis prophylaxis according to published guidelines.
- HIV infection.
- Parent or guardian must be available to give written informed consent.
Key exclusion criteria (27 listed)
- Zidovudine (AZT).
- Steroid dependency.
- Drugs that might interfere with the absorption of study drug (H2 blockers, antacids, carafate, cholestyramine).
- Benzodiazepines.
- Alcohol-containing substances.
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 |
|---|---|---|
| Nevirapine | 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 1 Mar 2011.
- Background: PubMed 8843207Luzuriaga K, Bryson Y, McSherry G, Robinson J, Stechenberg B, Scott G, Lamson M, Cort S, Sullivan JL. Pharmacokinetics, safety, and activity of nevirapine in human immunodeficiency virus type 1-infected children. J Infect Dis. 1996 Oct;174(4):713-21. doi: 10.1093/infdis/174.4.713.
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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 study testing Nevirapine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 6 inclusion and 27 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 1 Mar 2011. 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?
On the ClinicalTrials.gov record for NCT00000634, 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 1 Mar 2011.