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

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: HIV Infections

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02249130

1182.3

Details and patient eligibility

About

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)

Enrollment: 18 patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Treatment of HIV- infected patients

Experimental group

Description:

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

Treatment:

Drug: Zidovudine (ZDV)

Drug: Stavudine (d4T)

Drug: Ritonavir (RTV)

Drug: Delavirdine (DLV)

Drug: Lamivudine (3TC)

Drug: Tipranavir (TPV)