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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002368
• Other study ID #: 200E
• Secondary ID: 1100.1090
• Status: Completed
• Phase: Phase 3
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: August 2002
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Nevirapine

• Lamivudine

Locations

Country	Name	City	State
United States	Beth Israel Hosp / Virology Research Clinic	Boston	Massachusetts
United States	New England Deaconess Hosp	Boston	Massachusetts
United States	New England Med Ctr	Boston	Massachusetts
United States	SUNY / Erie County Med Ctr at Buffalo	Buffalo	New York
United States	Med Univ of South Carolina / Div of Infect Dis	Charleston	South Carolina
United States	Dr John Pottage	Chicago	Illinois
United States	Northwestern Univ / Division of Infectious Diseases	Chicago	Illinois
United States	Rush Presbyterian / Saint Luke's Med Ctr / Infect Dis	Chicago	Illinois
United States	Infectious Disease Specialists	Colorado Springs	Colorado
United States	Dr Alfred Burnside	Columbia	South Carolina
United States	Nelson Tebedo Health Resource Ctr	Dallas	Texas
United States	Denver Public Health	Denver	Colorado
United States	Dr Miguel Mogyoros / Clinical Research Dept	Denver	Colorado
United States	Dr Daniel H Gervich	Des Moines	Iowa
United States	Anthony LaMarca	Fort Lauderdale	Florida
United States	North Broward Hosp District	Fort Lauderdale	Florida
United States	Dr Robert Schwartz	Fort Myers	Florida
United States	McGregor Clinic / Lee County Public Health Unit	Fort Myers	Florida
United States	Univ of Texas Med Branch / Div of Infectious Dis	Galveston	Texas
United States	Hampton Roads Med Specialists	Hampton	Virginia
United States	Hershey Med Ctr / Dept of Med / Div of Hematology	Hershey	Pennsylvania
United States	Houston Clinical Research Network / Div of Montrose Clinic	Houston	Texas
United States	Indiana Univ Med School	Indianapolis	Indiana
United States	Univ of Iowa	Iowa City	Iowa
United States	Walter Gaman	Irving	Texas
United States	P Andrew Coley	Jacksonville	Florida
United States	Trinity Lutheran Hosp / HIV Program	Kansas City	Missouri
United States	Univ of Kentucky Med Cntr / Dept of Med / Div of ID	Lexington	Kentucky
United States	Dr G Michael Wool	Los Angeles	California
United States	UCLA School of Medicine / Ctr for Research and Education	Los Angeles	California
United States	Goodgame Med Group	Maitland	Florida
United States	Dr Susie Sargent	Memphis	Tennessee
United States	International Medicine and Infectious Disease	Minneapolis	Minnesota
United States	Drug Research and Analysis Corp	Montgomery	Alabama
United States	Med Research Ctr	New Orleans	Louisiana
United States	Dr David Kaufman	New York	New York
United States	AIDS Research Ctr / Palo Alto VA Health Care System	Palo Alto	California
United States	Univ of Pennsylvania / Division of Infectious Diseases	Philadelphia	Pennsylvania
United States	Novum Inc	Pittsburgh	Pennsylvania
United States	The Research and Education Group	Portland	Oregon
United States	Omega Med Research	Providence	Rhode Island
United States	AIDS Community Research Consortium	Redwood City	California
United States	San Francisco Gen Hosp / UCSF AIDS Program	San Francisco	California
United States	ViRx Inc	San Francisco	California
United States	Advanced Research Management	Seattle	Washington
United States	Infectious Disease Associates of Central New Jersey	Somerville	New Jersey
United States	Saint Vincent Med Ctr	Staten Island	New York
United States	Infectious Disease Research Institute Inc	Tampa	Florida
United States	Harbor - UCLA Med Ctr	Torrance	California
United States	Associates in Med and Mental Health	Tulsa	Oklahoma
United States	Novum Inc	Washington	District of Columbia
United States	Palm Beach Research Ctr	West Palm Beach	Florida
United States	Wilmington Hosp	Wilmington	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United States,