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

NCT ID: NCT02249130

Last Updated: 2014-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-03-31

Brief 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)

Conditions

HIV Infections

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment of HIV- infected patients

14 days treatment with tipranavir, ritonavir, then 46 weeks of triple- treatment with delavirdine, zidovudine and lamivudine (stavudine for patients intolerant of zidovudine)

Group Type: EXPERIMENTAL

Tipranavir (TPV)

Intervention Type: DRUG

Ritonavir (RTV)

Intervention Type: DRUG

Delavirdine (DLV)

Intervention Type: DRUG

Zidovudine (ZDV)

Intervention Type: DRUG

Lamivudine (3TC)

Intervention Type: DRUG

Stavudine (d4T)

Intervention Type: DRUG

Interventions

Tipranavir (TPV)

Intervention Type: DRUG

Ritonavir (RTV)

Intervention Type: DRUG

Delavirdine (DLV)

Intervention Type: DRUG

Zidovudine (ZDV)

Intervention Type: DRUG

Lamivudine (3TC)

Intervention Type: DRUG

Stavudine (d4T)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1182.3

Identifier Type: -

Identifier Source: org_study_id