- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02249130
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
September 23, 2014 updated by: Boehringer Ingelheim
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
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)
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients with treatment-emergent adverse events
Time Frame: Up to 46 weeks
|
Up to 46 weeks
|
|
Number of patients with drug-related adverse events
Time Frame: Up to 46 weeks
|
Up to 46 weeks
|
|
Number of patients with AIDS clinical trials group (ACTG) grade 3 or 4 toxicity
Time Frame: Up to 46 weeks
|
Up to 46 weeks
|
|
Number of patients with a treatment toxicity leading to study discontinuation
Time Frame: Up to 46 weeks
|
Up to 46 weeks
|
|
Number of patients with serious treatment-emergent adverse events
Time Frame: Up to 46 weeks
|
Up to 46 weeks
|
|
Number of patients with changes in laboratory parameters
Time Frame: Up to 46 weeks
|
Only lab values associated with metabolic disorders
|
Up to 46 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 1999
Primary Completion (ACTUAL)
April 1, 2000
Study Registration Dates
First Submitted
September 23, 2014
First Submitted That Met QC Criteria
September 23, 2014
First Posted (ESTIMATE)
September 25, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
September 25, 2014
Last Update Submitted That Met QC Criteria
September 23, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antimetabolites
- Protease Inhibitors
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Ritonavir
- Lamivudine
- Zidovudine
- Stavudine
- Tipranavir
- Delavirdine
Other Study ID Numbers
- 1182.3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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