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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02184286
Recruitment Status : Terminated
First Posted : July 9, 2014
Last Update Posted : July 14, 2014
Information provided by (Responsible Party):
Boehringer Ingelheim

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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Nevirapine Drug: Saquinavir-sgc Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 1999
Actual Primary Completion Date : February 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Maximum observed concentration (Cmax) [ Time Frame: up to 12 hours post-dose on days 1 and 28 ]
  2. Time of maximum concentration (Tmax) [ Time Frame: up to 12 hours post-dose on days 1 and 28 ]
  3. Minimum observed concentration (Cmin) [ Time Frame: up to 12 hours post-dose on days 1 and 28 ]
  4. 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 ]
  5. Systemic clearance (Cl/F) [ Time Frame: up to 12 hours post-dose on days 1 and 28 ]

Secondary Outcome Measures :
  1. Change in HIV RNA levels [ Time Frame: Baseline and day 28 ]
  2. Change in cluster differentiation 4 positive (CD4+) count [ Time Frame: Baseline and day 28 ]
  3. Number of patients with adverse events [ Time Frame: up to 28 days ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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 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)

Responsible Party: Boehringer Ingelheim Identifier: NCT02184286     History of Changes
Other Study ID Numbers: 1100.1280
First Posted: July 9, 2014    Key Record Dates
Last Update Posted: July 14, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
HIV Protease Inhibitors
Protease Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors