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NCT00001766 · ClinicalTrials.gov registry record · Phase 1
Drug Interactions Among Anti-HIV Agents
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT00001766 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 22 participants.
The verdict
NCT00001766, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
This study examined the interactions of various drugs used to treat HIV infection in order to design larger studies of possible combinations for people who continue to have high viral levels despite combination therapy. HIV-infected patients 18 years of age and older who have a viral load of at least 500 copies/mL; who have received 20 weeks of protease inhibitor therapy, with the same protease inhibitors in combination therapy for the last 12 weeks; and who have never been treated with abacavir, amprenavir or efavirenz were enrolled. All patients will receive 600 milligrams a day of efavirenz (a non-nucleoside reverse transcriptase inhibitor); 300 mg twice daily of abacavir (a nucleoside analog); and 1200 mg twice a day of amprenavir (a protease inhibitor). In addition to these drugs, six patients will receive 500 mg twice a day of ritonavir (a protease inhibitor); six patients will receive 200 mg twice a day of ritonavir; and 10 will receive 1250 mg twice a day of nelfinavir (a protease inhibitor). Patients in the two ritonavir groups (500-mg and 200-mg dose groups) took abacavir and amprenavir for one week and then come to the clinic for blood tests to measure drug levels before taking their morning pills and at 1/2, 1, 2, 4, 8, and 12 hours after taking the medicines. They will then add ritonavir to their treatment regimen. After one week, they will return for blood tests as before. They will then add efavirenz to their regimen and had bloods drawn again after another 1 or 2 weeks. Patients in the nelfinavir group took abacavir, amprenavir and nelfinavir for one week and then have blood sampling as described above for the ritonavir group. They will then add efavirenz to the regimen and repeat the blood tests again after another 1 or 2 weeks. Participants are being seen in the clinic for follow-up only if they wish to continue to participate and if the regimen appears to offer clinical benefit.
Interventions
- DRUG Amprenavir, Efavirenz, Abacavir, Nelfinavir, Ritonavir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 1998-08 |
| Est. Completion | 2003-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001766
The ClinicalTrials.gov registry entry for NCT00001766 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Amprenavir, Efavirenz, Abacavir, Nelfinavir, Ritonavir is the first listed.
NCT00001766 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001766 about?
NCT00001766 is a clinical study titled "Drug Interactions Among Anti-HIV Agents". This study examined the interactions of various drugs used to treat HIV infection in order to design larger studies of possible combinations for people who continue to have high viral levels despite combination therapy. HIV-infected patients 18 years of age and older who have a viral load of at lea...
What is the current status of trial NCT00001766?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 1998-08. Estimated completion is 2003-08.
What interventions are being tested in trial NCT00001766?
The interventions under investigation include: Amprenavir, Efavirenz, Abacavir, Nelfinavir, Ritonavir (DRUG).
Who is sponsoring clinical trial NCT00001766?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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