Dual Boosted - Protease Inhibitor (PI) Pharmacokinetics (PK) Trial (Tipranavir / Ritonavir) in Highly Treatment-experienced HIV-1 Infected Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 11 December 2023
• Main ID: NCT00056641
• Date of registration: 19/03/2003
• Prospective Registration: No
• Primary sponsor: Boehringer Ingelheim
• Public title: Dual Boosted - Protease Inhibitor (PI) Pharmacokinetics (PK) Trial (Tipranavir / Ritonavir) in Highly Treatment-experienced HIV-1 Infected Patients
• Scientific title: An Open Label, Randomized, Parallel-group Pharmacokinetics Trial of Tipranavir / Ritonavir (TPV/RTV), Alone or in Combination With RTV-boosted Saquinavir (SQV), Amprenavir (APV), or Lopinavir (LPV), Plus an Optimized Background Regimen, in Multiple Antiretroviral (ARV) Experienced Patients.
• Date of first enrolment: February 18, 2003
• Target sample size: 328
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT00056641
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Australia, Belgium, Canada, Denmark, France, Germany, Greece, Italy, Netherlands, Portugal, Switzerland, United Kingdom, United States

Contacts

• Name: Boehringer Ingelheim Study Coordinator
• Affiliation: Boehringer Ingelheim

Key inclusion & exclusion criteria

Inclusion criteria:

- Signed informed consent prior to trial participation.

- Human Immunodeficiency Virus type 1 (HIV-1) infected males or females =18 years of
age.

- Acceptable laboratory screening values in Trial 1182.12 (RESIST 1) or 1182.48 (RESIST
2), excluding genotype.

- Genotypic resistance report from screening visit of study RESIST 1 or RESIST 2
indicating at least three mutations at protease codons 33, 82, 84, and 90.

- At least 3 consecutive months experience taking ARVs from each of the classes of
Nucleoside reverse transcriptase inhibitors (NRTI), Non-nucleoside reverse
transcriptase inhibitor 1 (NNRTI), and Protease Inhibitor (PI) at some point in
treatment history, with at least 2 PI-based regimens, one of which must be part of the
current regimen, and current PI-based Anti-retroviral (ARV) medication regimen for at
least 3 months prior to randomization.

- HIV-1 viral load =1000 copies/mL at screening.

- Further inclusion criteria apply.

Exclusion criteria:

- Anti-retroviral (ARV) medication naïve.

- Patients on recent drug holiday, defined as off ARV medications for at least 7
consecutive days within the last 3 months.

- Female patients of child-bearing potential who:

- have a positive serum pregnancy test at screening or during the study,

- are breast feeding,

- are planning to become pregnant,

- are not willing to a use barrier method of contraception, or

- require ethinyl estradiol administration.

- Prior tipranavir use.

- Use of investigational medications within 30 days before study entry or during the
trial.

- Further exclusion criteria apply.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

HIV Infections

Intervention(s)

Drug: lopinavir

Drug: tipranavir

Drug: ritonavir

Drug: amprenavir

Drug: saquinavir

Primary Outcome(s)

Occurrence of adverse events; Proportion of patients with laboratory abnormalities; Proportion of patients with SAEs [Time Frame: week 4]

Change of the 2nd Protease Inhibitor (PI) (APV, LPV. SQV) mean concentration (C12h) [Time Frame: Day 14 to Day 28]

Secondary Outcome(s)

Mean concentration (C12h) of TPV (PI/TPV/r group); Mean concentration (C12h) of RTV (PI/TPV/r group) [Time Frame: Week 3 and 4]

Mean concentration (C12h) of TPV (TPV/r group); Mean concentration (C12h) of RTV (TPV/r group) [Time Frame: Week 1 and 2]

AUC(0-12h) of RTV; Cmax of RTV; C12h of RTV [Time Frame: week 2 and 4]

Assessment of patient adherence [Time Frame: Week 1 to 4]

Change in AUC(0-12h) of RTV from week 2; Change in Cmax of RTV from week 2; Change in C12h of RTV from week 2 [Time Frame: week 4]

Change in viral load; Proportion of virologic responders [Time Frame: week 2, 4, 8, 16 and 24]

Area under the Curve (AUC(0-12h)) of the 2nd PI (APV, LPV. SQV); Maximum concentration (Cmax) of the 2nd PI (APV, LPV. SQV); Concentration (C12h) of the 2nd PI (APV, LPV. SQV) [Time Frame: week 2 and 4]

Change in AUC(0-12h) of TPV from week 2; Change in Cmax of TPV from week 2; Change in C12h of TPV from week 2 [Time Frame: week 4]

Secondary ID(s)

1182.51

Source(s) of Monetary Support

Please refer to primary and secondary sponsors