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NCT00148785 · ClinicalTrials.gov registry record · Phase 4
A Pharmacokinetic (PK) Study of a Combination of Indinavir, Ritonavir, and Amprenavir
A Phase 4 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 4
- Development phase
- 15
- Enrollment target
NCT00148785 is a Phase 4 study that has completed, run by Emory University. The registered enrollment target is 15 participants.
The verdict
NCT00148785, a Phase 4 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 15 participants
- Enrollment target
Study Summary
When individuals who are infected with HIV are started on treatment with HIV medications, the effect of these drugs only lasts for a limited period of time, often because of development of drug resistance by the HIV virus. When this happens, such patients have to be switched to different combinations of HIV medications. However, since the availability of new HIV drugs that are active against resistant virus is limited, HIV care providers are resorting to curtail medications that contain three or more protease inhibitors (PIs). The reason for this is Norvir (ritonavir), a PI that has the ability to boost or increase the blood levels of other PIs in a way that can sometimes overcome the resistance of HIV virus. In addition, it may be more difficult for the virus to overcome two or more drugs with high blood levels, than it is to overcome just one. For these reasons, many clinicians are now using Norvir in combination with two other PIs, including Crixivan (indinavir) plus Lexiva (fosamprenavir), for treating patients who have been exposed to many other HIV medications. While this may be the case, researchers also know that when two or more PIs are combined, the effects each drug may have on the blood level of other drugs could be different. For example, researchers know from some recent studies that the combination of Norvir, Lexiva, and Kaletra, another PI, leads to an unacceptably low level of both Kaletra and Lexiva. Because researchers can not always assume that when multiple HIV medications are combined, the levels will remain high enough to be effective, the investigators think it will always be reasonable that, before any combination of drugs are used on HIV-infected patients, the effect a combination has on the levels of each of the drugs in the combination should be investigated. AIMS: The aim of this pilot study therefore is to examine the blood levels of Crixivan, Lexiva, and Norvir when these three drugs are used together as part of a combination treatme
Interventions
- DRUG Indinavir/Ritonavir/Fosamprenavir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2005-07 |
| Est. Completion | 2007-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00148785
The ClinicalTrials.gov registry entry for NCT00148785 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Indinavir/Ritonavir/Fosamprenavir is the first listed.
NCT00148785 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00148785 about?
NCT00148785 is a clinical study titled "A Pharmacokinetic (PK) Study of a Combination of Indinavir, Ritonavir, and Amprenavir". When individuals who are infected with HIV are started on treatment with HIV medications, the effect of these drugs only lasts for a limited period of time, often because of development of drug resistance by the HIV virus. When this happens, such patients have to be switched to different combination...
What is the current status of trial NCT00148785?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 15 participants. The study started on 2005-07. Estimated completion is 2007-01.
What interventions are being tested in trial NCT00148785?
The interventions under investigation include: Indinavir/Ritonavir/Fosamprenavir (DRUG).
Who is sponsoring clinical trial NCT00148785?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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