Pharmacokinetics of Low Dose Raltegravir
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ClinicalTrials.gov Identifier: NCT01159132 |
Recruitment Status
:
Completed
First Posted
: July 9, 2010
Last Update Posted
: November 1, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: raltegravir | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Official Title: | Pharmacokinetics of Low Dose Raltegravir |
Study Start Date : | April 2010 |
Actual Primary Completion Date : | December 2010 |
Actual Study Completion Date : | December 2010 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
RAL 400 mg OD
|
Drug: raltegravir
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.
|
Active Comparator: 2
RAL 800 mg OD
|
Drug: raltegravir
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.
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- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01159132
Thailand | |
HIV-NAT | |
Bangkok, Thailand, 10330 |
Principal Investigator: | Jintanat Ananworanich, MD, PhD | The HIV Netherlands Australia Thailand Research Collaboration |
Additional Information:
Responsible Party: | The HIV Netherlands Australia Thailand Research Collaboration |
ClinicalTrials.gov Identifier: | NCT01159132 History of Changes |
Other Study ID Numbers: |
HIV-NAT 127 |
First Posted: | July 9, 2010 Key Record Dates |
Last Update Posted: | November 1, 2011 |
Last Verified: | October 2011 |
Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:
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. |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Raltegravir Potassium Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents HIV Integrase Inhibitors Integrase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |