HIV InfectionsPhase 3NCT00038636
A Study of Two Different Doses of ABT-378/Ritonavir in HIV-Infected Patients Who Have Taken Protease Inhibitors and Non-Nucleoside Reverse Transcriptase Inhibitors
A Phase 3 study testing Lopinavir/ritonavir and Ritonavir in people with HIV Infections, run by Abbott at 7 sites in 3 countries.
Trial summary
The purpose of this study is to determine the safety and effectiveness of a high dose of ABT-378/ritonavir 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 Ritonavir
- How many people
- 36 participants
- Where
- 7 sitesin 3 countries
- Study dates
- Sep 2000to not given
- Phase
- Phase 3
- 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
- HIV positive
- Are at least 18 years old
- Subject has not been treated for an active AIDS-defining opportunistic infection within 15 days of screening
- HIV RNA level > 1000 copies/mL
- Previous therapy with at least one protease inhibitor, at least one non-nucleoside reverse transcriptase inhibitor and at least one nucleoside reverse transcriptase inhibitor
Who cannot join
- Subject is pregnant or breast-feeding
- Subject has received an investigational drug within 30 days prior to screening
- Have a history of pancreatitis
- History of intolerance to ritonavir
- Abnormal laboratory tests at screening
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
United States3 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21287
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
UCSD Treatment Center
San Diego, California, 92103-6329
France2 sites
Hopital Pitie-Salpetriere
Paris, 75651
Hospital Europeen Georges Pompidou
Paris, 75908
Spain2 sites
Hospital Clinico de Barcelona
Barcelona, 08036
Ciutat Sanitaria de Bellvitge
Barcelona, 08907
About this study
The purpose of this study is to determine the safety and effectiveness of a high dose of ABT-378/ritonavir
- Conditions
- HIV Infections
- Being tested
- Lopinavir/ritonavir, Ritonavir
- Keywords
- HIV
- 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
RitonavirDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Virologic and immunologic activity evaluations include plasma HIV RNA, CD4 and CD8 cell counts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2002 (estimated)
- Study startSep 2000
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Eugene Sun, M.D., Study chair, Divisional Vice President, Infectious Diseases and Virology Dept.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00038636
- Sponsor's protocol ID
- M99-049
- Status last verified
- Aug 2006
- First submitted
- 3 Jun 2002
- Last updated
- 15 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Two Different Doses of ABT-378/Ritonavir in HIV-Infected Patients Who Have Taken Protease Inhibitors and Non-Nucleoside Reverse Transcriptase Inhibitors
- ClinicalTrials.gov ID
- NCT00038636
- Acronym / sponsor ID
- M99-049
- Conditions
- HIV Infections
- Keywords
- HIV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Sep 2000
- First posted
- 4 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 determine the safety and effectiveness of a high dose of ABT-378/ritonavir
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- HIV positive
- Are at least 18 years old
- Subject has not been treated for an active AIDS-defining opportunistic infection within 15 days of screening
- HIV RNA level > 1000 copies/mL
- Previous therapy with at least one protease inhibitor, at least one non-nucleoside reverse transcriptase inhibitor and at least one nucleoside reverse transcriptase inhibitor
Key exclusion criteria (5 listed)
- Subject is pregnant or breast-feeding
- Subject has received an investigational drug within 30 days prior to screening
- Have a history of pancreatitis
- History of intolerance to ritonavir
- Abnormal laboratory tests at screening
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 | – |
| Ritonavir | Drug | – |
Primary outcome
Virologic and immunologic activity evaluations include plasma HIV RNA, CD4 and CD8 cell counts
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 15 Aug 2006.
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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.
Eugene Sun, M.D. study chair
Divisional Vice President, Infectious Diseases and Virology Dept.
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lopinavir/ritonavir and Ritonavir in people with HIV Infections, run by Abbott at 7 sites in 3 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 5 inclusion and 5 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 15 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, France, Spain. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.
What does the primary outcome measure?
Virologic and immunologic activity evaluations include plasma HIV RNA, CD4 and CD8 cell counts. It is what the study was designed to measure, not a finding.
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 15 Aug 2006.