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

NCT02249130 | Completed Phase 2

• 1 other identifier: 1182.3
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (6)

• Number of patients with treatment-emergent adverse events

  Up to 46 weeks

• Number of patients with drug-related adverse events

  Up to 46 weeks

• Number of patients with AIDS clinical trials group (ACTG) grade 3 or 4 toxicity

  Up to 46 weeks

• Number of patients with a treatment toxicity leading to study discontinuation

  Up to 46 weeks

• Number of patients with serious treatment-emergent adverse events

  Up to 46 weeks

• Number of patients with changes in laboratory parameters

  Only lab values associated with metabolic disorders

  Up to 46 weeks

Study Arms (1)

Treatment of HIV- infected patients

EXPERIMENTAL

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

Drug: Tipranavir (TPV); Drug: Ritonavir (RTV); Drug: Delavirdine (DLV); Drug: Zidovudine (ZDV); Drug: Lamivudine (3TC); Drug: Stavudine (d4T)

Interventions

Tipranavir (TPV) DRUG

Treatment of HIV- infected patients

Ritonavir (RTV) DRUG

Treatment of HIV- infected patients

Delavirdine (DLV) DRUG

Treatment of HIV- infected patients

Zidovudine (ZDV) DRUG

Treatment of HIV- infected patients

Lamivudine (3TC) DRUG

Treatment of HIV- infected patients

Stavudine (d4T) DRUG

Treatment of HIV- infected patients

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

HIV Infections

Interventions

tipranavir; Ritonavir; Delavirdine; Zidovudine; Lamivudine; Stavudine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Thymidine; Pyrimidine Nucleosides; Pyrimidines; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Zalcitabine; Deoxycytidine; Cytidine

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2014
• First Posted: September 25, 2014
• Study Start: March 1, 1999
• Primary Completion: April 1, 2000
• Last Updated: September 25, 2014

Record last verified: 2014-09