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

Primary Purpose

HIV Infections

Status

Terminated

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Nevirapine

Saquinavir-sgc

About this trial

This is an interventional treatment trial for HIV Infections

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nevirapine + Saquinavir-sgc

Arm Description

Outcomes

Primary Outcome Measures

Maximum observed concentration (Cmax)

Time of maximum concentration (Tmax)

Minimum observed concentration (Cmin)

Area under the plasma concentration time profile over the steady-state dosing interval (AUCτ)

Systemic clearance (Cl/F)

Secondary Outcome Measures

Change in HIV RNA levels

Change in cluster differentiation 4 positive (CD4+) count

Number of patients with adverse events

Full Information

NCT ID

NCT02184286

First Posted

July 8, 2014

Last Updated

July 11, 2014

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT02184286

Brief Title

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

Official Title

An Investigation of the Potential Pharmacokinetic Interaction Between Nevirapine (VIRAMUNE®) and Saquinavir-sgc (Fortovase®) in HIV-1 Infected Patients

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Terminated

Study Start Date

May 1999 (undefined)

Primary Completion Date

February 2000 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nevirapine + Saquinavir-sgc

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Nevirapine

Intervention Description

200 mg q.d. days 1-14 followed by 200 mg b.i.d. days 15-28

Intervention Type

Drug

Intervention Name(s)

Saquinavir-sgc

Intervention Description

1600 mg b.i.d. from pre trial to day 28

Primary Outcome Measure Information:

Title

Maximum observed concentration (Cmax)

Time Frame