HealthyPhase 4RAL-KALNCT00564772
Raltegravir Kaletra Pharmacokinetics
A Phase 4 study testing Raltegravir, lopinavir, ritonavir in people with Healthy, run by Allina Health System at 1 site in United States.
Trial summary
This will be an open-label, 3-period, fixed sequence study in young, healthy, male and female subjects of the pharmacokinetic interaction between raltegravir and Kaletra. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Raltegravir, lopinavir, ritonavir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Dec 2007
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, male or female, age 18-55.
- Anti-HIV, anti-HCV, HBsAg negative.
- Normal history and physical at screening.
- Normal complete blood count, creatinine and ALT at screening.
- Negative urine pregnancy test at screening.
- BMI 18-30.
Who cannot join
- Donated blood in the month before Day 1.
- Participated in another research study in the month before Day 1.
- Tobacco use in the 3 months before Day 1, unwillingness to avoid tobacco use during the study.
- Use of any illegal drug in the year before Day 1, positive drug screen for an illegal drug at screening.
- Unwillingness to restrict coffee use to 6 or fewer cups of coffee during the study.
- Unwillingness on the part of fertile female subjects to be abstinent or to use two effective birth control methods, one of which is a barrier method, for any vaginal intercourse.
- Unwillingness to avoid use of any prescribed medication during the study
- Allergy to RAL, lopinavir or ritonavir.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Sequential, 3-Period Study to Evaluate Pharmacokinetics of Coadministered Raltegravir (Isentress) and Lopinavir-Ritonavir (Kaletra) in Healthy Adults
This will be an open-label, 3-period, fixed sequence study in young, healthy, male and female subjects of the pharmacokinetic interaction between raltegravir and Kaletra.
Read the detailed description
This will be an open-label, 3-period, fixed sequence study in young, healthy, male and female subjects. The initial cohort, to be studied simultaneously, will be 15 subjects with intention to collect complete data from 12 subjects. Replacements will be subsequently enrolled if necessary. Subjects will be reimbursed.
The periods will be
- Period 1: Raltegravir (RAL) 400 mg q12h for 4 days (7 doses of RAL).
- Period 2: Kaletra 200 mg 2 pills bid for 10 days (19 doses of Kaletra).
- Period 3: both regimens for 4 days (7 doses of both drugs). All morning doses will be observed at Prism Research, Inc. Evening doses will be distributed each morning. 12 hour PK studies will be done on the last day of each period. Specimens will be obtained 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours after the morning dose of the last dosing day of each period.
- Conditions
- Healthy
- Being tested
- Raltegravir, lopinavir, ritonavir
- Keywords
- raltegravir, lopinavir, ritonavir, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Raltegravir, lopinavir, ritonavirDrug
Also called Isentress, Kaletra
4 days of raltegravir, then 10 days of Kaletra, then 4 days of both with 12 PK sampling at the end of each period.
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | all subjects dosed the same Receives: Drug: Raltegravir, lopinavir, ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
drug levels of lopinavir, ritonavir, raltegravir
Measured: 2 months
Secondary outcomes (1)
safety
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allina Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frank S Rhame, MD, Principal investigator, Allina Hospitals & Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00564772
- Sponsor's protocol ID
- 78958
- Other IDs
- Allina IRB No. 2366-1, Prism Research No. 714, FDA IND No. 78958
- Acronym
- RAL-KAL
- Status last verified
- Mar 2019
- First submitted
- 27 Nov 2007
- Last updated
- 20 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Sequential, 3-Period Study to Evaluate Pharmacokinetics of Coadministered Raltegravir (Isentress) and Lopinavir-Ritonavir (Kaletra) in Healthy Adults
- ClinicalTrials.gov ID
- NCT00564772
- Acronym / sponsor ID
- RAL-KAL / 78958
- Conditions
- Healthy
- Keywords
- raltegravir, lopinavir, ritonavir, pharmacokinetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Allina Health SystemUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 28 Nov 2007 (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.
This will be an open-label, 3-period, fixed sequence study in young, healthy, male and female subjects of the pharmacokinetic interaction between raltegravir and Kaletra.
Detailed description
This will be an open-label, 3-period, fixed sequence study in young, healthy, male and female subjects. The initial cohort, to be studied simultaneously, will be 15 subjects with intention to collect complete data from 12 subjects. Replacements will be subsequently enrolled if necessary. Subjects will be reimbursed.
The periods will be
- Period 1: Raltegravir (RAL) 400 mg q12h for 4 days (7 doses of RAL).
- Period 2: Kaletra 200 mg 2 pills bid for 10 days (19 doses of Kaletra).
- Period 3: both regimens for 4 days (7 doses of both drugs). All morning doses will be observed at Prism Research, Inc. Evening doses will be distributed each morning. 12 hour PK studies will be done on the last day of each period. Specimens will be obtained 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours after the morning dose of the last dosing day of each period.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Drug: Raltegravir, lopinavir, ritonavirall subjects dosed the same |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy, male or female, age 18-55.
- Anti-HIV, anti-HCV, HBsAg negative.
- Normal history and physical at screening.
- Normal complete blood count, creatinine and ALT at screening.
- Negative urine pregnancy test at screening.
Key exclusion criteria (8 listed)
- Donated blood in the month before Day 1.
- Participated in another research study in the month before Day 1.
- Tobacco use in the 3 months before Day 1, unwillingness to avoid tobacco use during the study.
- Use of any illegal drug in the year before Day 1, positive drug screen for an illegal drug at screening.
- Unwillingness to restrict coffee use to 6 or fewer cups of coffee during 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 |
|---|---|---|
| Raltegravir, lopinavir, ritonavirAlso: Isentress, Kaletra4 days of raltegravir, then 10 days of Kaletra, then 4 days of both with 12 PK sampling at the end of each period. | Drug | single arm |
Primary outcome
drug levels of lopinavir, ritonavir, raltegravir
Time frame: 2 months
1 secondary outcome
safety
Time frame: 2 months
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 Mar 2019.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Frank S Rhame, MD principal investigator
Allina Hospitals & Clinics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Raltegravir, lopinavir, ritonavir in people with Healthy, run by Allina Health System 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 8 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 Mar 2019. 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.
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?
drug levels of lopinavir, ritonavir, raltegravir (time frame: 2 months). 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 20 Mar 2019.