Clinical trial NCT00002368: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
Nevirapine
Lamivudine
Disease Progression
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 2000
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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