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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-25
Enrollment: 18
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)


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

Primary outcomes:
measure: Number of patients with treatment-emergent adverse events
timeFrame: Up to 46 weeks
measure: Number of patients with drug-related adverse events
timeFrame: Up to 46 weeks
measure: Number of patients with AIDS clinical trials group (ACTG) grade 3 or 4 toxicity
timeFrame: Up to 46 weeks
measure: Number of patients with a treatment toxicity leading to study discontinuation
timeFrame: Up to 46 weeks
measure: Number of patients with serious treatment-emergent adverse events
timeFrame: Up to 46 weeks
measure: Number of patients with changes in laboratory parameters
timeFrame: Up to 46 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: