A Randomised Trial to Evaluate the Antiviral Efficacy and Safety of Treatment With 500 mg Tipranavir (TPV) Plus 100 mg or 200 mg Ritonavir (RTV) p.o. BID in Comparison to 400 mg Lopinavir (LPV) Plus 100 mg RTV p.o. BID in Combination With Standard Background Regimen in ARV Therapy naïve Patients.

A Randomised, Open Label, Active Controlled Trial to Evaluate the Antiviral Efficacy and Safety of Treatment With 500 mg Tipranavir Plus 100 mg or 200 mg Ritonavir p.o. BID in Combination With Standard Background Regimen in Comparison to 400 mg Lopinavir Plus 100 mg Ritonavir p.o. BID in Combination With Standard Background Regimen in Antiretroviral Therapy Naive Patients for 48 With Extension up to 156 Weeks

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00144105

Enrollment

562

Registered

2005-09-05

Start date

2004-02-29

Completion date

Unknown

Last updated

2013-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Brief summary

Evaluation of safety and efficacy of Tipranavir (TPV) boosted with Ritonavir (RTV) versus an active control arm (Lopinavir / RTV) in antiretroviral (ARV) therapy naïve HIV-1 infected patients

Interventions

DRUGTPV500mg/RTV200mgBID

DRUGTPV500mg/RTV100mgBID

DRUGLPV400mg/RTV100mgBID

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Signed informed consent prior to trial participation. 2. HIV-1 infected males or females \>= 18 years of age. 3. No previous ARV therapy. 4. Any CD4+ T lymphocyte count \< 500 cells / µl. 5. HIV-1 viral load \>= 5000 copies/mL at screening. 6. Screening laboratory values that indicate adequate baseline organ function. 7. A prior AIDS defining event is acceptable as long as it has resolved or the subject has been on stable treatment (e.g. opportunistic infection; no ARV) for at least 2 weeks before screening

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the proportion of treatment responders at 48 weeks. A treatment responder is a patient with a viral load (VL) less than 50 copies/mL measured at two consecutive visits without prior rebound or change of ARV therapy.	—

Secondary

Measure	Time frame
Further analyses to evaluate the primary endpoint at 24, 96, and 156 weeks. Secondary endpoints include proportion of patients with VL< 400 copies/mL, change from baseline in CD4+ cell counts at each visit, time to a new CDC class C progression event.	—

Countries

Argentina, Australia, Brazil, Canada, Colombia, France, Germany, Mexico, Poland, Romania, Russia, Spain, Thailand, The Bahamas, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026