Tipranavir Dose-response Study Using a Prototype Self-emulsifying Drug Delivery System (SEDDS) Formulation in Treatment-naive HIV-1 Infected Patients Report on the Post-study Option, a Treatment of Triple Therapy With Delavirdine, ZDV and 3TC Without Tipranavir

HIV Infections Clinical Trial

Official title:

Tipranavir (PNU-140690): A Fourteen Day Dose-response Study Using a Prototype Self-emulsifying Drug Delivery System (SEDDS) Formulation in Treatment-naive HIV-1 Infected Patients. Report on the Post-study Option, a 46-week Treatment Period of Triple Therapy With Delavirdine, ZDV and 3TC Without Tipranavir

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02249130
• Other study ID #: 1182.3
• Status: Completed
• Phase: Phase 2
• First received: September 23, 2014
• Last updated: September 23, 2014
• Start date: March 1999

Study information

• Verified date: September 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSouth Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial Summary

To investigate the safety of a standard triple therapy regimen of delavirdine (DLV), zidovudine (ZDV), and lamivudine (3TC) following 14 days of experimental treatment with regimens of tipranavir (TPV) with and without ritonavir (RTV)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. primary completion date: April 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

Inclusion Criteria:

• HIV-1 RNA = 5,000 copies/mL by Roche Amplicor assay

• CD4 cell count = 50 cells/mm3

• Karnofsky performance status = 80

• Age = 13 years

• Screening laboratory values indicative of adequate baseline organ function, Grade 0 or 1 for laboratory values based on the ACTG toxicity scale grade. Selected stable [2 months or longer] Grade 2 laboratory abnormalities were subject to sponsor's approval

• Acceptable medical history and physical examination

• Agreement to use a barrier contraceptive method for at least 1 month prior to the administration of the study medication, during the study, and for 30 days after the end of the study

• Signed informed consent

• To enter the post-study option, patients have to have completed the 14-day tipranavir phase of the trial

Exclusion Criteria:

• Previous treatment with any antiretroviral drugs for more than 2 weeks

• Clinically significant, active and/or acute (onset within the prior month) medical problems including opportunistic infections, such as active cryptococcosis, Pneumocystis carinii pneumonia (PCP), herpes zoster, histoplasmosis or cytomegalovirus (CMV) , or non-opportunistic diseases including, but not limited to, progressive multifocal leukoencephalopathy, lymphoma, or malignancy requiring systemic therapy

• History of clinically significant nervous system or muscle diseases, seizure disorder, or psychiatric disorder that might impair compliance with the study

• Receipt of any known enzyme-inducing drugs including rifabutin, rifampin, carbamazepine, dexamethasone, phenobarbital, phenytoin, sulfamidine, sulfinpyrazone, or troleandomycin within 30 days prior to participation in the study

• Receipt of any investigational medication within 30 days prior to participation in the study

• Receipt of oral contraceptives within 30 days prior to participation in the study

• Pregnancy or lactation (serum ß-human chorionic gonadotropin (ß-HCG) test negative at second screen visit of the tipranavir phase of trial)

• Evidence of active substance abuse that, in the investigator's opinion, could affect study adherence

• In the investigator's judgment, inability to comply with the protocol requirements for reasons other than those specified above

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Tipranavir (TPV)

• Ritonavir (RTV)

• Delavirdine (DLV)

• Zidovudine (ZDV)

• Lamivudine (3TC)

• Stavudine (d4T)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with treatment-emergent adverse events		Up to 46 weeks	No
Primary	Number of patients with drug-related adverse events		Up to 46 weeks	No
Primary	Number of patients with AIDS clinical trials group (ACTG) grade 3 or 4 toxicity		Up to 46 weeks	No
Primary	Number of patients with a treatment toxicity leading to study discontinuation		Up to 46 weeks	No
Primary	Number of patients with serious treatment-emergent adverse events		Up to 46 weeks	No
Primary	Number of patients with changes in laboratory parameters	Only lab values associated with metabolic disorders	Up to 46 weeks	No

External Links

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