Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02184286
First received: July 8, 2014
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Nevirapine
Drug: Saquinavir-sgc
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Investigation of the Potential Pharmacokinetic Interaction Between Nevirapine (VIRAMUNE®) and Saquinavir-sgc (Fortovase®) in HIV-1 Infected Patients

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Maximum observed concentration (Cmax) [ Time Frame: up to 12 hours post-dose on days 1 and 28 ] [ Designated as safety issue: No ]
  • Time of maximum concentration (Tmax) [ Time Frame: up to 12 hours post-dose on days 1 and 28 ] [ Designated as safety issue: No ]
  • Minimum observed concentration (Cmin) [ Time Frame: up to 12 hours post-dose on days 1 and 28 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Systemic clearance (Cl/F) [ Time Frame: up to 12 hours post-dose on days 1 and 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in HIV RNA levels [ Time Frame: Baseline and day 28 ] [ Designated as safety issue: No ]
  • Change in cluster differentiation 4 positive (CD4+) count [ Time Frame: Baseline and day 28 ] [ Designated as safety issue: No ]
  • Number of patients with adverse events [ Time Frame: up to 28 days ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: May 1999
Primary Completion Date: February 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nevirapine + Saquinavir-sgc Drug: Nevirapine
200 mg q.d. days 1-14 followed by 200 mg b.i.d. days 15-28
Drug: Saquinavir-sgc
1600 mg b.i.d. from pre trial to day 28

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02184286     History of Changes
Other Study ID Numbers: 1100.1280
Study First Received: July 8, 2014
Last Updated: July 11, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Nevirapine
Saquinavir
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Protease Inhibitors
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014