HIV InfectionPhase 4NCT00234975
Safety of Lopinavir/Ritonavir (Kaletra) in HIV/HCV Co-infected Subjects vs Baseline Liver Biopsy Metavir Score
A Phase 4 study testing Lopinavir/Ritonavir in people with HIV Infection, run by AbbVie (prior sponsor, Abbott) at 11 sites in Puerto Rico.
Trial summary
The purpose of this study is to evaluate clinical response and safety of a Kaletra containing antiretroviral treatment regimen in HIV positive subjects with HCV coinfection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection
- What is being tested?
- Lopinavir/Ritonavir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 11 sitesPuerto Rico
- Study dates
- Oct 2002to Jan 2008
- Phase
- Phase 4
- 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
- Documented HIV positive.
- At least 18 years of age.
- Does not exhibit evidence of acute illness (especially any acute liver disease, except hepatitis C)
- Subject has not been treated for an active opportunistic infection within 30 days of the baseline visit.
- Subject Has a Karnofsky Score greater than or equal to 70.
- Subject does not require and agrees not to take, for the duration of the study, any of the following medications that are contraindicated with Kaletra: astemizole, terfenadine, midazolam, triazolam, cisapride, certain ergot derivatives (ergotamine, dihydroergotamine, ergonovine, and methylergonovine), pimozide, propafenone and flecainide. Rifampin, a potent enzyme inducer, should not be administered with the study medication, because of the possibility of significant decreases in Kaletra concentration during concurrent administration.
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- The subject agrees not to take any medication, including over-the-counter medicine, alcohol, recreational drugs or herbal preparations without the knowledge and permission of the principal investigator.
- Subject had laboratory testing within the previous three months and the most recent testing demonstrates all of the following: Hemoglobin> 8.0 g/dL; absolute neutrophil count > 750 cells/mL; Platelet count > 20,000/mL; ALT or AST </=10 x upper limit of normal (ULN); Creatinine< 1.5 x ULN; Triglycerides </=750 mg/dL.
- Subjects have no evidence of grade III or IV adverse event or laboratory abnormality (except for LFTs).
Who cannot join
- No exclusion criteria.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Puerto Rico11 sites
Site Reference ID/Investigator# 4118
Bayamón, 00960
Site Reference ID/Investigator# 4119
Bayamón, 00961
Site Reference ID/Investigator# 6298
Juana Diaz, 00795
Site Reference ID/Investigator# 6284
Las Piedras, 00771
Site Reference ID/Investigator# 4101
Mayagüez, 00680
Site Reference ID/Investigator# 4116
Playa de Ponce, 00731
Site Reference ID/Investigator# 4117
Ponce, 00717-1563
Site Reference ID/Investigator# 4099
Ponce, 00731
Site Reference ID/Investigator# 4086
Rio Piedras, 00926
Site Reference ID/Investigator# 4080
San Juan, 00908
Site Reference ID/Investigator# 4100
Santurce, 00909
About this study
Official title: Evaluation of Clinical Response and Safety in HIV Positive Subjects Co-infected With Hepatitis C Treated With a Kaletra Containing HAART Regimen
The purpose of this study is to evaluate clinical response and safety of a Kaletra containing antiretroviral treatment regimen in HIV positive subjects with HCV coinfection.
- Conditions
- HIV Infection
- Being tested
- Lopinavir/Ritonavir
- Keywords
- Lopinavir, Ritonavir, Phase 4, 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
Also called ABT-378, lopinavir/ritonavir, Kaletra
400 mg/ 100 mg BID. Both arms use Kaletra 400/100 mg BID, plus NRTI chosen by the investigator
| Study group | Role | What they receive |
|---|---|---|
| HCV + | Active comparator | Not described Receives: Drug: Lopinavir/Ritonavir |
| HCV - | Active comparator | Not described Receives: Drug: Lopinavir/Ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure
Changes in liver functions enzyme.
Measured: Baseline, Week 4, Week 8, Week 16 and Week 24
Secondary outcomes (1)
Secondary Outcome Measures
Changes in HIV viral load, CD4/CD8 cell count, and Hepatitis C viral load
Measured: Baseline, Week 4, Week 8, Week 16 and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2005 (estimated)
- Study startOct 2002
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carlos R Rivera-Vazquez, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00234975
- Sponsor's protocol ID
- PUER-02-003
- Status last verified
- Jan 2013
- First submitted
- 13 Sep 2005
- Last updated
- 3 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Response and Safety in HIV Positive Subjects Co-infected With Hepatitis C Treated With a Kaletra Containing HAART Regimen
- ClinicalTrials.gov ID
- NCT00234975
- Acronym / sponsor ID
- PUER-02-003
- Conditions
- HIV Infection
- Keywords
- Lopinavir, Ritonavir, Phase 4, HIV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- Oct 2002
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 10 Oct 2005 (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 evaluate clinical response and safety of a Kaletra containing antiretroviral treatment regimen in HIV positive subjects with HCV coinfection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCV + | Active comparator | Drug: Lopinavir/Ritonavir |
| HCV - | Active comparator | Drug: Lopinavir/Ritonavir |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Documented HIV positive.
- At least 18 years of age.
- Does not exhibit evidence of acute illness (especially any acute liver disease, except hepatitis C)
- Subject has not been treated for an active opportunistic infection within 30 days of the baseline visit.
- Subject Has a Karnofsky Score greater than or equal to 70.
Key exclusion criteria (1 listed)
- No exclusion criteria.
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/RitonavirAlso: ABT-378, lopinavir/ritonavir, Kaletra400 mg/ 100 mg BID. Both arms use Kaletra 400/100 mg BID, plus NRTI chosen by the investigator | Drug | HCV +, HCV - |
Primary outcome
Primary Outcome Measure
Time frame: Baseline, Week 4, Week 8, Week 16 and Week 24
Changes in liver functions enzyme.
1 secondary outcome
Secondary Outcome Measures
Time frame: Baseline, Week 4, Week 8, Week 16 and Week 24
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 3 Jan 2013.
- Related InfoLink provided by the sponsor.
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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.
Carlos R Rivera-Vazquez, MD study director
AbbVie
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lopinavir/Ritonavir in people with HIV Infection, run by AbbVie (prior sponsor, Abbott) at 11 sites in Puerto Rico.
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 9 inclusion and 1 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 3 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Puerto Rico. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Primary Outcome Measure (time frame: Baseline, Week 4, Week 8, Week 16 and Week 24). 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 3 Jan 2013.