NCT02184286TerminatedPhase 1
An Investigation of the Potential Pharmacokinetic Interaction Between Nevirapine (VIRAMUNE®) and Saquinavir-sgc (Fortovase®) in HIV-1 Infected Patients
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 5
- Primary Endpoint
- Time of maximum concentration (Tmax)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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)
Arms & Interventions
Nevirapine + Saquinavir-sgc
Experimental
Intervention: Nevirapine (Drug)
Nevirapine + Saquinavir-sgc
Experimental
Intervention: Saquinavir-sgc (Drug)
Outcomes
Primary Outcomes
Time of maximum concentration (Tmax)
Time Frame: up to 12 hours post-dose on days 1 and 28
Area under the plasma concentration time profile over the steady-state dosing interval (AUCτ)
Time Frame: up to 12 hours post-dose on days 1 and 28
Systemic clearance (Cl/F)
Time Frame: up to 12 hours post-dose on days 1 and 28
Maximum observed concentration (Cmax)
Time Frame: up to 12 hours post-dose on days 1 and 28
Minimum observed concentration (Cmin)
Time Frame: up to 12 hours post-dose on days 1 and 28
Secondary Outcomes
- Change in cluster differentiation 4 positive (CD4+) count(Baseline and day 28)
- Change in HIV RNA levels(Baseline and day 28)
- Number of patients with adverse events(up to 28 days)
Investigators
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