Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00344123 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic (PK) Study of Single-dose Rosuvastatin and Tipranavir/Ritonavir in Healthy Subjects
A Phase 1 study of HIV Infections, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
- 1
- Study location
NCT00344123: Completed Phase 1 study of HIV Infections, sponsored by Johns Hopkins University.
NCT00344123 is a Phase 1 study of HIV Infections that has completed, run by Johns Hopkins University. The registered enrollment target is 29 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00344123, a Phase 1 study of HIV Infections, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
- 1
- Study location
Study Summary
Tipranavir (TPV) plus ritonavir (RTV) is indicated for use as part of an antiretroviral treatment regimen for resistant HIV-1 infection in adult patients. Since significant cholesterol and triglyceride elevations are commonly reported during TPV/RTV treatment, effective treatment strategies are critical to prevent long-term cardiovascular events. Rosuvastatin, a potent 3-hydroxy-3-methylglutaryl-coenzyme (HMG-CoA) reductase inhibitor, is unlikely to interact with TPV/RTV since it is not extensively metabolized, however, a formal drug interaction study is needed before this combination can be recommended. This study will examine the pharmacokinetic interactions between tipranavir/ritonavir (TPV/RTV \[TPV/r\] 500 mg/200 mg twice daily \[B.I.D\]) and single dose rosuvastatin when the two are co-administered to healthy adult volunteers. The investigators hypothesize that if tipranavir 500 mg is co-administered with low-dose ritonavir 200 mg and rosuvastatin (10 mg) no significant clinical interaction will occur.
Conditions Studied
Interventions
- DRUG Rosuvastatin
- DRUG Tipranavir/Ritonavir
Study Locations (1)
Maryland
- Johns Hopkins University - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2007-02 |
| Est. Completion | 2008-05 |
| Phase | Phase 1 |
What the finished NCT00344123 record still lists
NCT00344123 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (93% lower).
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 2 interventions - of which Rosuvastatin is the first listed.
NCT00344123 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00344123 about?
NCT00344123 is a clinical study titled "Pharmacokinetic (PK) Study of Single-dose Rosuvastatin and Tipranavir/Ritonavir in Healthy Subjects". Tipranavir (TPV) plus ritonavir (RTV) is indicated for use as part of an antiretroviral treatment regimen for resistant HIV-1 infection in adult patients. Since significant cholesterol and triglyceride elevations are commonly reported during TPV/RTV treatment, effective treatment strategies are crit...
What is the current status of trial NCT00344123?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2007-02. Estimated completion is 2008-05.
What conditions does trial NCT00344123 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT00344123?
The interventions under investigation include: Rosuvastatin (DRUG), Tipranavir/Ritonavir (DRUG).
Who is sponsoring clinical trial NCT00344123?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00344123 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV Infections
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00344123's enrollment target sits among peer trials
29 442nd of 542 higher than 97 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
CAR-T Cells for HIV Infection
RECRUITING · Phase 1
-
A Study to Investigate the Use of VH3810109 With or Without Fostemsavir (FTR) to Reduce the Size and Activity of the Viral Reservoir in People Living With HIV
RECRUITING · Phase 1
-
Clinical Trial to Evaluate the Safety and Immunogenicity of Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env (VRIPRO) in Adult Participants Who Previously Participated in HVTN 706
RECRUITING · Phase 1
-
Pharmacokinetics, Safety, Tolerability of Dolutegravir/Rilpivirine in Pediatrics
RECRUITING · Phase 1
-
A Study to Investigate Pharmacokinetics, Safety and Tolerability of Long-Acting Cabotegravir Plus Recombinant Human Hyaluronidase PH20 in Healthy Adult Participants
RECRUITING · Phase 1
-
First Time in Human Study of Long Acting VH4524184 Formulations
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02429557 · 29 participants · Phase 1
Hemodynamic Mechanisms of Abdominal Compression in the Treatment of Orthostatic Hypotension in Autonomic Failure
- NCT02568878 · 29 participants · Phase 3
Creatine for Depressed Male and Female Methamphetamine Users
- NCT03014401 · 29 participants · NA
The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis
- NCT03128996 · 29 participants · Phase 1
Reduced Intensity Conditioning and Familial HLA-Mismatched BMT for Non-Malignant Disorders
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia