Human Immunodeficiency Virus InfectionNCT01328158
Drug Use Investigation of Kaletra Tablets (Once Daily Administration) on Patients With HIV-infection
An observational study of Human Immunodeficiency Virus Infection, run by AbbVie (prior sponsor, Abbott) at 23 sites in Japan.
Trial summary
This study of Kaletra (Lopinavir (LPV)/Ritonavir (RTV)) tablets will be conducted to clarify the following with regard to treatment with this drug: 1. Incidence and conditions of occurrence of adverse reactions in the clinical setting 2. Factors that may affect the safety and effectiveness of Kaletra (QD) Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Human Immunodeficiency Virus Infection
- How many people
- 236 participants
- Where
- 23 sitesJapan
- Study dates
- Jun 2011to Dec 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All participants who receive Kaletra for the treatment of Human Immunodeficiency Virus infection per approved label
Who may be able to join
- Participants who were receiving Kaletra or who started Kaletra therapy during the registration period.
Who cannot join
- Participants with a history of hypersensitivity to any ingredient of this drug.
- Participants who are undergoing treatment with any of the following drugs: pimozide, ergotamine tartrate, dihydroergotamine mesilate, ergometrine maleate, methylergometrine maleate, midazolam, triazolam, vardenafil hydrochloride hydrate, sildenafil citrate (Revatio), tadalafil (Adcirca), blonanserin, azelnidipine, rivaroxaban, voriconazole.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
Japan23 sites
Site Reference ID/Investigator# 57629
Fukuoka
Site Reference ID/Investigator# 57630
Hiroshima
Site Reference ID/Investigator# 57631
Hokkaido
Site Reference ID/Investigator# 57628
Kitakyushu-shi
Site Reference ID/Investigator# 57638
Kurashiki-shi
Site Reference ID/Investigator# 57634
Kyoto
Site Reference ID/Investigator# 57625
Nagoya
Site Reference ID/Investigator# 57626
Nagoya
Site Reference ID/Investigator# 57637
Niigata
Site Reference ID/Investigator# 57632
Nishinomiya-shi
Site Reference ID/Investigator# 57639
Osaka
Site Reference ID/Investigator# 57640
Osaka
Site Reference ID/Investigator# 57636
Sendai
Site Reference ID/Investigator# 48722
Tokyo
Site Reference ID/Investigator# 57641
Tokyo
Site Reference ID/Investigator# 57643
Tokyo
Site Reference ID/Investigator# 57644
Tokyo
Site Reference ID/Investigator# 57645
Tokyo
Site Reference ID/Investigator# 57646
Tokyo
Site Reference ID/Investigator# 57647
Tokyo
Site Reference ID/Investigator# 57648
Tokyo
Site Reference ID/Investigator# 57650
Tokyo
Site Reference ID/Investigator# 57633
Yokohama
About this study
Official title: Drug Use Investigation of Kaletra Tablets (Quaque Die, QD) on Patients With HIV-infection
This study of Kaletra (Lopinavir (LPV)/Ritonavir (RTV)) tablets will be conducted to clarify the following with regard to treatment with this drug:
- Incidence and conditions of occurrence of adverse reactions in the clinical setting
- Factors that may affect the safety and effectiveness of Kaletra (QD)
- Conditions
- Human Immunodeficiency Virus Infection
- Keywords
- Kaletra, Lopinavir (LPV)/Ritonavir (RTV), Human Immunodeficiency Virus (HIV) infection
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lopinavir/Ritonavir | Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Adverse Drug Reactions
Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".
Measured: Up to 60 Months
Number of Adverse Drug Reactions
Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".
Measured: Up to 60 Months
Secondary outcomes (31)
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Gender
Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".
Measured: Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Pregnancy
Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".
Measured: Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Age
Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".
Measured: Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Inpatient/Outpatient
Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".
Measured: Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Previous Treatment of Human Immunodeficiency Virus (HIV)-Infection
Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".
Measured: Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Races
Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".
Measured: Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Route of Infection
Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".
Measured: Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Disease Duration
Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".
Measured: Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Past Medical History
Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".
Measured: Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Allergy
Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".
Measured: Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Diseases
Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".
Measured: Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Renal Disorder
Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".
Measured: Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Liver Disorder
Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".
Measured: Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Haemophilia
Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".
Measured: Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Haemophilia With/Without Hepatitis C
Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".
Measured: Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Center for Disease Control (CDC) Classification Category of Severity Before Treatment
Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".
Measured: Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Administration Method of Lopinavir/Ritonavir
Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".
Measured: Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Mean Daily Dose of Lopinavir/Ritonavir
Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".
Measured: Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Use Duration of Lopinavir/Ritonavir
Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".
Measured: Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Anti-HIV Concomitant Drugs
Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".
Measured: Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Anti-HIV Concomitant Non-Drug Treatments
Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".
Measured: Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Types of Concomitant Anti-HIV Drugs
Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown". Abbreviations for the following terminologies are used to represent results in below table: NRTIs: Nucleoside Reverse Transcriptase Inhibitors, NNRTIs: Non-Nucleoside Reverse Transcriptase Inhibitors.
Measured: Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Drugs Other Than Anti-HIV Drugs
Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".
Measured: Up to 60 Months
Number of Participants With Serious Adverse Events
A serious adverse event is an adverse event that 1. requires in patient hospitalization or prolongation of existing hospitalization, 2. results in persistent or significant disability/incapacity, 3. is life-threatening, 4. results in death, 5. is a congenital anomaly/birth defect, or 6. is an important medical event other than the above.
Measured: Up to 60 Months
Mean Cluster of Differentiation 4 (CD4) Cell Count in Treatment-Naive Participants at Each Time Point of Observation
Measured: Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir
Mean CD4 Cell Count in Treatment-Experienced Participants at Each Time Point of Observation
Measured: Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir
Mean HIV Ribonucleic Acid (RNA) Amount in Treatment-Naive Participants at Each Time Point of Observation
For subjects with plasma HIV-1 RNA quantified as < 400 copies/mL, the result was recorded as 399 copies/mL.
Measured: Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir
Mean HIV RNA Amount in Treatment-Experienced Participants at Each Time Point of Observation
For subjects with plasma HIV-1 RNA quantified as < 400 copies/mL, the result was recorded as 399 copies/mL.
Measured: Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir
Number of Participants in Each CDC Classification Category of HIV-infection Over Time
CDC Categories include Category A: asymptomatic acute phase, Category B: symptomatic other than A or C, and Category C: having an AIDS-indicator disease.
Measured: Up to Month 60 after first dose of Lopinavir/Ritonavir
Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Naive Participants
Participants whose number of plasma HIV-1 RNA copies was less than 400 copies/mL after the start of treatment were handled as responders. For subjects with plasma HIV-1 RNA quantified as < 400 copies/mL, the result was recorded as 399 copies/mL.
Measured: Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir
Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Experienced Participants
Participants whose number of plasma HIV-1 RNA copies was less than 400 copies/mL after the start of treatment were handled as responders. For subjects with plasma HIV-1 RNA quantified as < 400 copies/mL, the result was recorded as 399 copies/mL.
Measured: Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Human Immunodeficiency Virus 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Susumu Adachi, MD, Study director, AbbVie G.K.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01328158
- Sponsor's protocol ID
- P12-760
- Status last verified
- Dec 2014
- First submitted
- 1 Apr 2011
- Last updated
- 22 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Use Investigation of Kaletra Tablets (Quaque Die, QD) on Patients With HIV-infection
- ClinicalTrials.gov ID
- NCT01328158
- Acronym / sponsor ID
- P12-760
- Conditions
- Human Immunodeficiency Virus Infection
- Keywords
- Kaletra, Lopinavir (LPV)/Ritonavir (RTV), Human Immunodeficiency Virus (HIV) infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 4 Apr 2011 (estimated)
- Results
- Posted 22 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study of Kaletra (Lopinavir (LPV)/Ritonavir (RTV)) tablets will be conducted to clarify the following with regard to treatment with this drug:
- Incidence and conditions of occurrence of adverse reactions in the clinical setting
- Factors that may affect the safety and effectiveness of Kaletra (QD)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lopinavir/Ritonavir | – | –Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All participants who receive Kaletra for the treatment of Human Immunodeficiency Virus infection per approved label
Key inclusion criteria (1 listed)
- Participants who were receiving Kaletra or who started Kaletra therapy during the registration period.
Key exclusion criteria (2 listed)
- Participants with a history of hypersensitivity to any ingredient of this drug.
- Participants who are undergoing treatment with any of the following drugs: pimozide, ergotamine tartrate, dihydroergotamine mesilate, ergometrine maleate, methylergometrine maleate, midazolam, triazolam, vardenafil hydrochloride hydrate, sildenafil citrate (Revatio), tadalafil (Adcirca), blonanserin, azelnidipine, rivaroxaban, voriconazole.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Participants With Adverse Drug Reactions
Time frame: Up to 60 Months
Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".
Number of Adverse Drug Reactions
Time frame: Up to 60 Months
Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".
31 secondary outcomes
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Gender
Time frame: Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Pregnancy
Time frame: Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Age
Time frame: Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Inpatient/Outpatient
Time frame: Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Previous Treatment of Human Immunodeficiency Virus (HIV)-Infection
Time frame: Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Races
Time frame: Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Route of Infection
Time frame: Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Disease Duration
Time frame: Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Past Medical History
Time frame: Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Allergy
Time frame: Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Diseases
Time frame: Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Renal Disorder
Time frame: Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Liver Disorder
Time frame: Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Haemophilia
Time frame: Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Haemophilia With/Without Hepatitis C
Time frame: Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Center for Disease Control (CDC) Classification Category of Severity Before Treatment
Time frame: Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Administration Method of Lopinavir/Ritonavir
Time frame: Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Mean Daily Dose of Lopinavir/Ritonavir
Time frame: Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Use Duration of Lopinavir/Ritonavir
Time frame: Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Anti-HIV Concomitant Drugs
Time frame: Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Anti-HIV Concomitant Non-Drug Treatments
Time frame: Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Types of Concomitant Anti-HIV Drugs
Time frame: Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Drugs Other Than Anti-HIV Drugs
Time frame: Up to 60 Months
Number of Participants With Serious Adverse Events
Time frame: Up to 60 Months
Mean Cluster of Differentiation 4 (CD4) Cell Count in Treatment-Naive Participants at Each Time Point of Observation
Time frame: Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir
Mean CD4 Cell Count in Treatment-Experienced Participants at Each Time Point of Observation
Time frame: Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir
Mean HIV Ribonucleic Acid (RNA) Amount in Treatment-Naive Participants at Each Time Point of Observation
Time frame: Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir
Mean HIV RNA Amount in Treatment-Experienced Participants at Each Time Point of Observation
Time frame: Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir
Number of Participants in Each CDC Classification Category of HIV-infection Over Time
Time frame: Up to Month 60 after first dose of Lopinavir/Ritonavir
Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Naive Participants
Time frame: Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir
Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Experienced Participants
Time frame: Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Susumu Adachi, MD study director
AbbVie G.K.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Immunodeficiency Virus Infection, run by AbbVie (prior sponsor, Abbott) at 23 sites in Japan.
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 1 inclusion and 2 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 22 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Japan. 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?
Yes. Results are posted in the registry (first posted 22 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With Adverse Drug Reactions (time frame: Up to 60 Months). The study lists 2 primary outcomes in all. 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 22 Dec 2014.