HIV InfectionsPhase 1NCT00004580
A Study of ABT-378/Ritonavir Combination in HIV-Infected Patients Who Have Taken Protease Inhibitors
A Phase 1 study testing Lopinavir/Ritonavir and Nevirapine in people with HIV Infections, run by Abbott at 10 sites in United States.
Trial summary
The purpose of this study is to see if it is safe and effective to give ABT-378/ritonavir combination plus nevirapine plus two nucleoside transcriptase inhibitors to HIV-infected patients who previously have taken protease inhibitors. This study also examines how the body handles this combination of anti-HIV drugs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Lopinavir/Ritonavir and Nevirapine
- How many people
- Not given
- Where
- 10 sitesUnited 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- Antiretroviral regimen containing a protease inhibitor and one or two nucleoside reverse transcriptase inhibitors that has not changed in the last 12 weeks.
- Patients must have:
- HIV infection with plasma HIV RNA of at least 1,000 copies/ml and less than or equal to 100,000 copies/ml at screening.
- Prior Medication:
- Allowed:
- Naive to or has had less than 8 weeks of at least one nucleoside reverse transcriptase inhibitor and an acceptable regimen of two nucleoside reverse transcriptase inhibitors.
Who cannot join
- Concurrent Medication:
- Excluded:
- Medications that are contraindicated with ABT-378/ritonavir for the duration of the study, such as midazolam, triazolam, terfenadine, astemizole, cisapride, pimozide, ergotamine and dihydroergotamine.
- Over-the-counter medicine or alcohol, without knowledge or permission of the investigator.
- Patients with the following prior conditions are excluded:
- Evidence of acute illness determined by vital signs, physical examination, or laboratory results.
Show all 18Show fewer
- Clinically significant abnormal ECG results.
- Positive test result for drug abuse with the exception of cannabis, unless the investigator anticipates cannabis use will interfere with compliance with the study.
- Prior Medication:
- Excluded:
- Investigational drugs with the exception of Amprenavir within 28 days prior to the initiation of study dosing.
- Treatment with a non-nucleoside reverse transcriptase inhibitor.
- Treatment with a protease inhibitor different from the current protease inhibitor for more than 6 weeks prior to current regimen.
- Treatment with more than one protease inhibitor concurrently.
- Risk Behavior:
- Excluded:
- Active substance abuse, alcohol abuse, psychiatric illness.
- Presumption, by investigator, of poor compliance to regimen.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Infectious Disease Physicians Inc
Annandale, Virginia, 22203
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
Pacific Oaks Research
Beverly Hills, California, 90211
Univ North Carolina at Chapel Hill / Dept of Medicine
Chapel Hill, North Carolina, 27599
Rush Presbyterian St Lukes Med Ctr / Sect Infect Dise
Chicago, Illinois, 60612
Univ of Cincinnati Med Ctr / Holmes Div Mail Loc 0405
Cincinnati, Ohio, 452670405
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
Duke Univ Med Ctr / Infectious Disease Clinic
Durham, North Carolina, 27710
Univ of Pittsburgh
Pittsburgh, Pennsylvania, 152132582
San Francisco Gen Hosp / UCSF AIDS Program
San Francisco, California, 94110
About this study
Official title: Phase I/II Study of ABT-378/Ritonavir in Protease Inhibitor Experienced HIV-Infected Patients
The purpose of this study is to see if it is safe and effective to give ABT-378/ritonavir combination plus nevirapine plus two nucleoside transcriptase inhibitors to HIV-infected patients who previously have taken protease inhibitors. This study also examines how the body handles this combination of anti-HIV drugs.
- Conditions
- HIV Infections
- Being tested
- Lopinavir/Ritonavir, Nevirapine
- Keywords
- Drug Therapy, Combination, Nevirapine, HIV Protease Inhibitors, Ritonavir, Reverse Transcriptase Inhibitors
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lopinavir/RitonavirDrug
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)
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
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004580
- Sponsor's protocol ID
- 285B
- Other IDs
- M97-765
- Status last verified
- Feb 2009
- First submitted
- 2 Nov 1999
- Last updated
- 20 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of ABT-378/Ritonavir in Protease Inhibitor Experienced HIV-Infected Patients
- ClinicalTrials.gov ID
- NCT00004580
- Acronym / sponsor ID
- 285B
- Conditions
- HIV Infections
- Keywords
- Drug Therapy, Combination, Nevirapine, HIV Protease Inhibitors, Ritonavir, Reverse Transcriptase Inhibitors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- AbbottIndustry (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 and effective to give ABT-378/ritonavir combination plus nevirapine plus two nucleoside transcriptase inhibitors to HIV-infected patients who previously have taken protease inhibitors. This study also examines how the body handles this combination of anti-HIV drugs.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Antiretroviral regimen containing a protease inhibitor and one or two nucleoside reverse transcriptase inhibitors that has not changed in the last 12 weeks.
- HIV infection with plasma HIV RNA of at least 1,000 copies/ml and less than or equal to 100,000 copies/ml at screening.
- Naive to or has had less than 8 weeks of at least one nucleoside reverse transcriptase inhibitor and an acceptable regimen of two nucleoside reverse transcriptase inhibitors.
Key exclusion criteria (18 listed)
- Medications that are contraindicated with ABT-378/ritonavir for the duration of the study, such as midazolam, triazolam, terfenadine, astemizole, cisapride, pimozide, ergotamine and dihydroergotamine.
- Over-the-counter medicine or alcohol, without knowledge or permission of the investigator.
- Evidence of acute illness determined by vital signs, physical examination, or laboratory results.
- Clinically significant abnormal ECG results.
- Positive test result for drug abuse with the exception of cannabis, unless the investigator anticipates cannabis use will interfere with compliance with the study.
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 |
|---|---|---|
| Lopinavir/Ritonavir | Drug | – |
| 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 20 Feb 2009.
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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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lopinavir/Ritonavir and Nevirapine in people with HIV Infections, run by Abbott at 10 sites 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 8 inclusion and 18 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 20 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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 20 Feb 2009.