Pharmacokinetic Interaction Between Nevirapine and Saquinavir-sgc in HIV-1 Infected Patients

Boehringer Ingelheim

Status and phase

Terminated

Phase 1

Conditions

HIV Infections

Treatments

Drug: Saquinavir-sgc

Drug: Nevirapine

Study type

Interventional

Funder types

Industry

Identifiers

NCT02184286

1100.1280

Details and patient eligibility

About

The objectives of this study are to determine the effects of nevirapine on the steady-state pharmacokinetics of saquinavir-sgc and to determine the effects of saquinavir-sgc on the steady-state pharmacokinetics of nevirapine. This study will also evaluate the pharmacokinetics of nevirapine in combination with saquinavir-sgc compared to historical controls treated with nevirapine but without saquinavir-sgc.

Enrollment

5 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female patients between the ages of 18 and 65 years who are seropositive for HIV-1 antibody by an ELISA test and confirmed by an alternative method, e.g. Western blot
Patients who meet the following laboratory parameters:
- Granulocyte count ≥ 1000 cells/mm3
- Hemoglobin ≥ 9.0 g(dL (men and women)
- Platelet count ≥ 75,000 cells/mm3
- Alkaline phosphatase ≤ 3.0 times the upper limit of normal
- Serum glutamic oxalo-acetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) ≤ 3.0 times the upper limit of normal
- Total bilirubin ≤ 1.5 times the upper limit of normal
Patients receiving a stable antiretroviral regimen, including saquinavir-sgc (Fortovase®) 1600 mg b.i.d. in the 28 days prior to visit 1
Female patients of childbearing potential must be willing to use a reliable form of contraception, which should include a medically approved form of barrier contraception
Patients able to provide written informed consent and comply with study requirements
Patients with a viral load less than 400 copies/mL

Exclusion criteria

Female patients who are pregnant or breastfeeding
Patients requiring systemic treatment with corticosteroids or drugs known to be hepatic enzyme inducers or inhibitors in the 14 days prior to visit 1. Such substances in these categories include macrolide antibiotics (erythromycin, clarithromycin, azithromycin, dirithromycin), azole antifungals (ketoconazole, fluconazole, itraconazole), rifampin, rifabutin, and phenytoin
Patients with previous exposure to (or are currently being treated with) non-nucleoside reverse transcriptase inhibitors (NNRTIs)
Patients receiving a protease inhibitor other than saquinavir-sgc (Fortovase®) in the 28 days prior to visit 1
Patients receiving any investigational drug, antineoplastic agent or radiotherapy other than local skin radiotherapy treatment in the 12 weeks prior to visit 1
Patients with malabsorption, severe chronic diarrhea or patients unable to maintain adequate oral intake
Patients with a current history of intravenous drug abuse, alcohol or substance abuse (within the last year)
Patients undergoing treatment for an active infection
Patients who are heavy smokers (≥ 20 cigarettes or cigars per day)