Phase 2
Completed N=85
Tipranavir/Ritonavir Low Dose Pharmacokinetics in Treatment Naive Patients
Source: ClinicalTrials.gov NCT00530920 ↗Enrolled (actual)
85
Serious AEs
1.2%
Results posted
Jul 2009
Primary outcomePrimary: Viral Load (log10 Copies/mL) Change From Baseline (Last Observation Carried Forward (LOCF)) — -1.43; -1.55; -1.47 Log10 copies/mL — p=0.997
Summary
The purpose of this study is to identify an optimal dose combination(s) of tipranavir (TPV) and ritonavir (RTV) for antiretroviral treatment naïve HIV-1 infected patients that can be used in pivotal trial by assessing the steady-state pharmacokinetics and short-term efficacy and safety
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Viral Load (log10 Copies/mL) Change From Baseline (Last Observation Carried Forward (LOCF)) |
-1.43; -1.55; -1.47 | 0.997 |
| SECONDARY Apparent Oral Clearance I(Cl/F) of Tipranavir |
1.45; 1.43; 1.57 | — |
| SECONDARY Area Under the Curve(AUC) of Tipranavir 24 h for Once Daily (QD) and AUC 12 h for Twice Daily (BID) |
571.3; 289.3; 538.2 | — |
| SECONDARY Concentration-24 Hour (hr) Post Dose of Tipranavir - (Cp 24 h for QD and 12 hr Post Dose (CP 12h) for BID |
3.26; 10.27; 17.75 | — |
| SECONDARY Trough Concentration (Cmin) of Tipranavir |
2.8; 12.73; 21.26 | — |
| SECONDARY Maximum Concentration (Cmax) of Tipranavir |
54.64; 36.98; 69.66 | — |
| SECONDARY Volume of Distribution (V/F) of Tipranavir |
10.02; 9.33; 9.39 | — |
| SECONDARY Terminal Half-Life (t1/2) of Tipranavir |
4.79; 4.51; 4.14 | — |
| SECONDARY Time to Cmax (Tmax) of Tipranavir |
3.07; 2.34; 2.38 | — |
| SECONDARY AUC 24 of Ritonavir for QD and AUC 12 of Ritonavir for BID |
5.05; 2.25; 1.74 | — |
| SECONDARY Cp 24 h of Ritonavir for QD and CP 12 h of Ritonavir for BID |
0.005; 0.039; 0.025 | — |
| SECONDARY Apparent Oral Clearance I(Cl/F) of Ritonavir |
39.6; 44.4; 57.4 | — |
| SECONDARY Volume of Distribution (V/F) of Ritonavir |
97.5; 90.8; 88.9 | — |
| SECONDARY Terminal Half-Life (t1/2) of Ritonavir |
1.71; 1.42; 1.07 | — |
| SECONDARY Tmax of Ritonavir |
2.84; 2.33; 2.05 | — |
| SECONDARY Cmax of Ritonavir |
0.632; 0.346; 0.291 | — |
| SECONDARY Clinical Abnormal Findings in Laboratory and Physical Examination |
0; 0; 1; 0; 0; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Signed informed consent in accordance with GCP and local regulatory requirements prior to trial participation.
- HIV-1 infected men and non-pregnant women who are treatment naïve, with positive serology (EIA) confirmed by Western blot.
- Age > 18 and 200 cells/mm3
- Viral load (HIV-1 mRNA viral load) > 5,000 copies/mL.
- Ability to swallow multiple large capsules without difficulty.
- Acceptable laboratory values that indicate adequate baseline organ function at screening visit.
- Laboratory values are considered to be acceptable if the severity of any parameter is = 4).
Data sourced from ClinicalTrials.gov (NCT00530920). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.