HIV InfectionsPhase 2NCT01159132
Pharmacokinetics of Low Dose Raltegravir
A Phase 2 study testing raltegravir in people with HIV Infections, run by The HIV Netherlands Australia Thailand Research Collaboration at 1 site in Thailand.
Trial summary
The purpose of this study is to study and compare the pharmacokinetics profile of low dose raltegravir (RAL) (400mg OD and 800mg OD) and standard dose of 400mg BID in Thai HIV-infected patients. 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?
- raltegravir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteThailand
- Study dates
- Apr 2010to Dec 2010
- Phase
- Phase 2
- 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
- Signed informed consent
- Evidence of HIV infection
- Age> 18 years
- On RAL 400 mg BID containing HAART regimen with a VL < 50 copies for at least 3 months before enrollment
- Willing to adhere to the protocol requirements
Who cannot join
- Evidence of RAL resistance
- History of RAL allergy
- Use of concomitant medication that may interfere with the pharmacokinetics of RAL
- Current pregnancy or lactating or planning to get pregnant
- Active drug abuse or alcoholic
- Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to study and compare the pharmacokinetics profile of low dose raltegravir (RAL) (400mg OD and 800mg OD) and standard dose of 400mg BID in Thai HIV-infected patients.
Read the detailed description
Twenty four HIV-infected volunteers on stable doses of RAL 400 mg BID for at least 3 months and with undetectable viral load will be enrolled. On Day 1, all 24 subjects will attend the first intensive PK collection for RAL 400 mg BID and the blood samples will be drawn at T = 0.0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, and 12.0 hour post medication. All 24 subjects will be randomised (1:1) to either Group A (RAL 400 mg OD) or Group B (RAL 800 mg OD) for 14 days. On day 15, a second 24 hour intensive PK will be carried out and the blood samples will be drawn. After 2nd intensive PK, the subjects will switch to the other dosing regimen. Subjects in group A will receive RAL 800 mg OD and group B will receive RAL 400 mg OD for another 14 days. On day 29, the third 24 hour intensive PK will be carried out. After the 3rd intensive PK, all 24 subjects will be switched back to the initial regimen of RAL 400 mg BID.
- Conditions
- HIV Infections
- Being tested
- raltegravir
- Keywords
- pharmacokinetics, low dose raltegravir, HIV, To study the pharmacokinetics profile of low dose raltegravir (RAL) (400mg OD and 800mg OD) and standard dose of 400mg BID in Thai HIV-infected patients.
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
raltegravirDrug
12 hour PK will be done on day 1 while subjects is on stable regimen with RAL 400 mg BID. After performing intensive PK, subjects will be randomized to either group A (RAL 400 mg OD) or B (RAL 800 mg OD) for 14 days and on day 15, a second 24 hour full PK will be carried out. After the intensive PK, subjects in both the groups will switched to the other dosing regimen, group A (RAL 800 mg OD) and B (RAL 400 mg OD) for another 14 days and on day 29, the third 24 hour full PK will be carried out.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | RAL 400 mg OD Receives: Drug: raltegravir |
| 2 | Active comparator | RAL 800 mg OD Receives: Drug: raltegravir |
What is being measured
The primary outcome is the main question the study is designed to answer.
pharmacokinetics of RAL in Thais
To assess AUC, Cmax, Cmin, T 1/2, clearance of RAL at dose of 400 mg BID, 800 mg OD, 400 mg OD in Thai
Measured: 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2010
- Study completionDec 2010
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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- The HIV Netherlands Australia Thailand Research Collaboration
- Sponsor type
- University, hospital or other
- Collaborators
- National Healthcare Group Pte Ltd, Singapore, Chulalongkorn University
- Responsible party
- Sponsor
- Investigators
- Jintanat Ananworanich, MD, PhD, Principal investigator, The HIV Netherlands Australia Thailand Research Collaboration
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01159132
- Sponsor's protocol ID
- HIV-NAT 127
- Status last verified
- Jul 2020
- First submitted
- 9 Jun 2010
- Last updated
- 17 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Low Dose Raltegravir
- ClinicalTrials.gov ID
- NCT01159132
- Acronym / sponsor ID
- HIV-NAT 127
- Conditions
- HIV Infections
- Keywords
- pharmacokinetics, low dose raltegravir, HIV, To study the pharmacokinetics profile of low dose raltegravir (RAL) (400mg OD and 800mg OD) and standard dose of 400mg BID in Thai HIV-infected patients.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- The HIV Netherlands Australia Thailand Research CollaborationUniversity, hospital or other
- Collaborators
- National Healthcare Group Pte Ltd, Singapore, Chulalongkorn University
- Study start
- Apr 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 9 Jul 2010 (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 study and compare the pharmacokinetics profile of low dose raltegravir (RAL) (400mg OD and 800mg OD) and standard dose of 400mg BID in Thai HIV-infected patients.
Detailed description
Twenty four HIV-infected volunteers on stable doses of RAL 400 mg BID for at least 3 months and with undetectable viral load will be enrolled. On Day 1, all 24 subjects will attend the first intensive PK collection for RAL 400 mg BID and the blood samples will be drawn at T = 0.0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, and 12.0 hour post medication. All 24 subjects will be randomised (1:1) to either Group A (RAL 400 mg OD) or Group B (RAL 800 mg OD) for 14 days. On day 15, a second 24 hour intensive PK will be carried out and the blood samples will be drawn. After 2nd intensive PK, the subjects will switch to the other dosing regimen. Subjects in group A will receive RAL 800 mg OD and group B will receive RAL 400 mg OD for another 14 days. On day 29, the third 24 hour intensive PK will be carried out. After the 3rd intensive PK, all 24 subjects will be switched back to the initial regimen of RAL 400 mg BID.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: raltegravirRAL 400 mg OD |
| 2 | Active comparator | Drug: raltegravirRAL 800 mg OD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed informed consent
- Evidence of HIV infection
- Age> 18 years
- On RAL 400 mg BID containing HAART regimen with a VL < 50 copies for at least 3 months before enrollment
- Willing to adhere to the protocol requirements
Key exclusion criteria (6 listed)
- Evidence of RAL resistance
- History of RAL allergy
- Use of concomitant medication that may interfere with the pharmacokinetics of RAL
- Current pregnancy or lactating or planning to get pregnant
- Active drug abuse or alcoholic
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 |
|---|---|---|
| raltegravir12 hour PK will be done on day 1 while subjects is on stable regimen with RAL 400 mg BID. After performing intensive PK, subjects will be randomized to either group A (RAL 400 mg OD) or B (RAL 800 mg OD) for 14 days and on day 15, a second 24 hour full PK will be carried out. After the intensive PK, subjects in both the groups will switched to the other dosing regimen, group A (RAL 800 mg OD) and B (RAL 400 mg OD) for another 14 days and on day 29, the third 24 hour full PK will be carried out. | Drug | 1, 2 |
Primary outcome
pharmacokinetics of RAL in Thais
Time frame: 29 days
To assess AUC, Cmax, Cmin, T 1/2, clearance of RAL at dose of 400 mg BID, 800 mg OD, 400 mg OD in Thai
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 17 Jul 2020.
- HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)Link provided by the sponsor.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Jintanat Ananworanich, MD, PhD principal investigator
The HIV Netherlands Australia Thailand Research Collaboration
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing raltegravir in people with HIV Infections, run by The HIV Netherlands Australia Thailand Research Collaboration at 1 site in Thailand.
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 6 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 17 Jul 2020. 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 Thailand. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
pharmacokinetics of RAL in Thais (time frame: 29 days). 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 17 Jul 2020.