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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

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ClinicalTrials.gov Identifier: NCT02249130
Recruitment Status : Completed
First Posted : September 25, 2014
Last Update Posted : September 25, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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)

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Tipranavir (TPV) Drug: Ritonavir (RTV) Drug: Delavirdine (DLV) Drug: Zidovudine (ZDV) Drug: Lamivudine (3TC) Drug: Stavudine (d4T) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : March 1999
Actual Primary Completion Date : April 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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



Primary Outcome Measures :
  1. Number of patients with treatment-emergent adverse events [ Time Frame: Up to 46 weeks ]
  2. Number of patients with drug-related adverse events [ Time Frame: Up to 46 weeks ]
  3. Number of patients with AIDS clinical trials group (ACTG) grade 3 or 4 toxicity [ Time Frame: Up to 46 weeks ]
  4. Number of patients with a treatment toxicity leading to study discontinuation [ Time Frame: Up to 46 weeks ]
  5. Number of patients with serious treatment-emergent adverse events [ Time Frame: Up to 46 weeks ]
  6. Number of patients with changes in laboratory parameters [ Time Frame: Up to 46 weeks ]
    Only lab values associated with metabolic disorders



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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02249130     History of Changes
Other Study ID Numbers: 1182.3
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: September 25, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Ritonavir
Lamivudine
Zidovudine
Stavudine
Tipranavir
Delavirdine
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Antimetabolites