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The Safety and Effectiveness of Nevirapine Plus Lamivudine Plus Other Anti-HIV Drugs

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Nevirapine
Lamivudine
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Nevirapine, Lamivudine, Disease Progression, Reverse Transcriptase Inhibitors, Anti-HIV Agents

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Patients must have: Documented HIV infection. CD4+ cell count <= 200 cells/mm3. Life expectancy > 3 months. Written informed consent from parent or guardian for patients < 18 years of age. Willingness and ability to follow protocol requirements. Exclusion Criteria Co-existing Condition: Patients with any of the following conditions or symptoms are excluded: Patient is enrolled or plans to enroll during the course of this study in another clinical study of an antiretroviral or other agent used to treat HIV-1 infection. NOTE: Patients are allowed to participate in opportunistic infection clinical studies if the investigational agent is not contraindicated for the study. Concurrent Medication: Excluded: Patient is receiving therapy with an antiretroviral agent other than ZDV, d4T, ddI, ddC, or 3TC. Patient is receiving acute therapy for a clinical AIDS progression event such as systemic chemotherapy. Dicumarol, Warfarin and other anticoagulant medications. Tolbutamide. Investigational drugs (unless included in opportunistic infection clinical trial) and all antiretroviral agents (excluding ZDV, ddC, ddI, d4T and 3TC). Neurotoxic drugs. Cimetidine. Erythromycin. Concurrent Treatment: Excluded: Radiation therapy. Patients with any of the following prior conditions and symptoms are excluded: History of clinically important disease other than HIV-1 infection or related diseases that, in the opinion of the investigator, may put the patient at risk because of participation in this study. Prior Medication: Excluded: Patient has received prior therapy with Viramune or any other non-nucleoside reverse transcriptase inhibitor. Patient has received any immunosuppressive or cytotoxic drugs or any other experimental agent within 4 weeks prior to study day 1. Patient has received treatment with erythromycin, coumadin/warfarin, phenobarbital, amoxicillin/clavulanic acid, or ticarcillin/clavulanic acid within 2 weeks prior to study day 0. Risk Behavior: Excluded: Patients who are active chronic alcohol or substance abusers or have an active psychiatric condition sufficient to impair compliance with protocol requirements. Required: Patient must be receiving stable nucleoside therapy with at least one agent for >= 4 weeks prior to study day 0. Zidovudine (ZDV), Zidovudine + Dideoxycytidine (ddC), or Zidovudine + Didanosine (ddI) must be used unless prior intolerance precludes ZDV use. Stable use means no change in dose > 50% for any background nucleoside within four weeks prior to study day 0. NOTE: If patient is ZDV intolerant, ddC, ddI or D4T monotherapy is allowed.

Sites / Locations

  • Drug Research and Analysis Corp
  • Dr G Michael Wool
  • UCLA School of Medicine / Ctr for Research and Education
  • AIDS Research Ctr / Palo Alto VA Health Care System
  • AIDS Community Research Consortium
  • ViRx Inc
  • San Francisco Gen Hosp / UCSF AIDS Program
  • Harbor - UCLA Med Ctr
  • Infectious Disease Specialists
  • Denver Public Health
  • Dr Miguel Mogyoros / Clinical Research Dept
  • Wilmington Hosp
  • Novum Inc
  • Anthony LaMarca
  • North Broward Hosp District
  • Dr Robert Schwartz
  • McGregor Clinic / Lee County Public Health Unit
  • P Andrew Coley
  • Goodgame Med Group
  • Infectious Disease Research Institute Inc
  • Palm Beach Research Ctr
  • Dr John Pottage
  • Northwestern Univ / Division of Infectious Diseases
  • Rush Presbyterian / Saint Luke's Med Ctr / Infect Dis
  • Indiana Univ Med School
  • Dr Daniel H Gervich
  • Univ of Iowa
  • Univ of Kentucky Med Cntr / Dept of Med / Div of ID
  • Med Research Ctr
  • New England Med Ctr
  • Beth Israel Hosp / Virology Research Clinic
  • New England Deaconess Hosp
  • International Medicine and Infectious Disease
  • Trinity Lutheran Hosp / HIV Program
  • Infectious Disease Associates of Central New Jersey
  • SUNY / Erie County Med Ctr at Buffalo
  • Dr David Kaufman
  • Saint Vincent Med Ctr
  • Associates in Med and Mental Health
  • The Research and Education Group
  • Hershey Med Ctr / Dept of Med / Div of Hematology
  • Univ of Pennsylvania / Division of Infectious Diseases
  • Novum Inc
  • Omega Med Research
  • Med Univ of South Carolina / Div of Infect Dis
  • Dr Alfred Burnside
  • Dr Susie Sargent
  • Nelson Tebedo Health Resource Ctr
  • Univ of Texas Med Branch / Div of Infectious Dis
  • Houston Clinical Research Network / Div of Montrose Clinic
  • Walter Gaman
  • Hampton Roads Med Specialists
  • Advanced Research Management

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00002368
Brief Title
The Safety and Effectiveness of Nevirapine Plus Lamivudine Plus Other Anti-HIV Drugs
Official Title
An International, Double Blind, Randomized, Phase III Study to Evaluate the Tolerance, Safety, and Effectiveness of Viramune (Nevirapine) in Preventing Clinical AIDS Progression Events or Death When Used in Combination With Lamivudine (3TC) and Stable (>= 4 Weeks) Background Nucleoside Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2002
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary
To evaluate the tolerance, safety, and effectiveness of Viramune in preventing clinical AIDS progression events or death when used in combination with Lamivudine and background nucleoside therapy.
Detailed Description
Eligible patients will be randomized to treatment with either 1) open-label 3TC twice daily plus Viramune once daily for 2 weeks and then with Viramune twice daily; or 2) open label 3TC twice daily plus Viramune placebo once daily for 2 weeks and then twice daily Viramune. Patients will start Viramune and 3TC on study day 0. Patients will be evaluated for development of AIDS progression events at months 1, 2, 3, and 4, and every 2 months thereafter until 18 months after the last patient is enrolled or 24 months, whichever occurs first.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Nevirapine, Lamivudine, Disease Progression, Reverse Transcriptase Inhibitors, Anti-HIV Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Enrollment
2000 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Nevirapine
Intervention Type
Drug
Intervention Name(s)
Lamivudine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Patients must have: Documented HIV infection. CD4+ cell count <= 200 cells/mm3. Life expectancy > 3 months. Written informed consent from parent or guardian for patients < 18 years of age. Willingness and ability to follow protocol requirements. Exclusion Criteria Co-existing Condition: Patients with any of the following conditions or symptoms are excluded: Patient is enrolled or plans to enroll during the course of this study in another clinical study of an antiretroviral or other agent used to treat HIV-1 infection. NOTE: Patients are allowed to participate in opportunistic infection clinical studies if the investigational agent is not contraindicated for the study. Concurrent Medication: Excluded: Patient is receiving therapy with an antiretroviral agent other than ZDV, d4T, ddI, ddC, or 3TC. Patient is receiving acute therapy for a clinical AIDS progression event such as systemic chemotherapy. Dicumarol, Warfarin and other anticoagulant medications. Tolbutamide. Investigational drugs (unless included in opportunistic infection clinical trial) and all antiretroviral agents (excluding ZDV, ddC, ddI, d4T and 3TC). Neurotoxic drugs. Cimetidine. Erythromycin. Concurrent Treatment: Excluded: Radiation therapy. Patients with any of the following prior conditions and symptoms are excluded: History of clinically important disease other than HIV-1 infection or related diseases that, in the opinion of the investigator, may put the patient at risk because of participation in this study. Prior Medication: Excluded: Patient has received prior therapy with Viramune or any other non-nucleoside reverse transcriptase inhibitor. Patient has received any immunosuppressive or cytotoxic drugs or any other experimental agent within 4 weeks prior to study day 1. Patient has received treatment with erythromycin, coumadin/warfarin, phenobarbital, amoxicillin/clavulanic acid, or ticarcillin/clavulanic acid within 2 weeks prior to study day 0. Risk Behavior: Excluded: Patients who are active chronic alcohol or substance abusers or have an active psychiatric condition sufficient to impair compliance with protocol requirements. Required: Patient must be receiving stable nucleoside therapy with at least one agent for >= 4 weeks prior to study day 0. Zidovudine (ZDV), Zidovudine + Dideoxycytidine (ddC), or Zidovudine + Didanosine (ddI) must be used unless prior intolerance precludes ZDV use. Stable use means no change in dose > 50% for any background nucleoside within four weeks prior to study day 0. NOTE: If patient is ZDV intolerant, ddC, ddI or D4T monotherapy is allowed.
Facility Information:
Facility Name
Drug Research and Analysis Corp
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36104
Country
United States
Facility Name
Dr G Michael Wool
City
Los Angeles
State/Province
California
ZIP/Postal Code
90067
Country
United States
Facility Name
UCLA School of Medicine / Ctr for Research and Education
City
Los Angeles
State/Province
California
ZIP/Postal Code
900951793
Country
United States
Facility Name
AIDS Research Ctr / Palo Alto VA Health Care System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
AIDS Community Research Consortium
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
ViRx Inc
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
San Francisco Gen Hosp / UCSF AIDS Program
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Harbor - UCLA Med Ctr
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Infectious Disease Specialists
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80903
Country
United States
Facility Name
Denver Public Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Dr Miguel Mogyoros / Clinical Research Dept
City
Denver
State/Province
Colorado
ZIP/Postal Code
80205
Country
United States
Facility Name
Wilmington Hosp
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19801
Country
United States
Facility Name
Novum Inc
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Anthony LaMarca
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
North Broward Hosp District
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Dr Robert Schwartz
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
McGregor Clinic / Lee County Public Health Unit
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
P Andrew Coley
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Goodgame Med Group
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Infectious Disease Research Institute Inc
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Palm Beach Research Ctr
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Dr John Pottage
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Facility Name
Northwestern Univ / Division of Infectious Diseases
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush Presbyterian / Saint Luke's Med Ctr / Infect Dis
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Indiana Univ Med School
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Dr Daniel H Gervich
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Facility Name
Univ of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Univ of Kentucky Med Cntr / Dept of Med / Div of ID
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40563
Country
United States
Facility Name
Med Research Ctr
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
New England Med Ctr
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Beth Israel Hosp / Virology Research Clinic
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
New England Deaconess Hosp
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
International Medicine and Infectious Disease
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Trinity Lutheran Hosp / HIV Program
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Infectious Disease Associates of Central New Jersey
City
Somerville
State/Province
New Jersey
ZIP/Postal Code
08876
Country
United States
Facility Name
SUNY / Erie County Med Ctr at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Dr David Kaufman
City
New York
State/Province
New York
ZIP/Postal Code
10014
Country
United States
Facility Name
Saint Vincent Med Ctr
City
Staten Island
State/Province
New York
ZIP/Postal Code
10310
Country
United States
Facility Name
Associates in Med and Mental Health
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74114
Country
United States
Facility Name
The Research and Education Group
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Hershey Med Ctr / Dept of Med / Div of Hematology
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Univ of Pennsylvania / Division of Infectious Diseases
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Novum Inc
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
152063817
Country
United States
Facility Name
Omega Med Research
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02907
Country
United States
Facility Name
Med Univ of South Carolina / Div of Infect Dis
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Dr Alfred Burnside
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29206
Country
United States
Facility Name
Dr Susie Sargent
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Facility Name
Nelson Tebedo Health Resource Ctr
City
Dallas
State/Province
Texas
ZIP/Postal Code
75219
Country
United States
Facility Name
Univ of Texas Med Branch / Div of Infectious Dis
City
Galveston
State/Province
Texas
ZIP/Postal Code
775550835
Country
United States
Facility Name
Houston Clinical Research Network / Div of Montrose Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77006
Country
United States
Facility Name
Walter Gaman
City
Irving
State/Province
Texas
ZIP/Postal Code
75038
Country
United States
Facility Name
Hampton Roads Med Specialists
City
Hampton
State/Province
Virginia
ZIP/Postal Code
23666
Country
United States
Facility Name
Advanced Research Management
City
Seattle
State/Province
Washington
ZIP/Postal Code
981225314
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Safety and Effectiveness of Nevirapine Plus Lamivudine Plus Other Anti-HIV Drugs

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