HIV InfectionsPhase 3NCT00002368
The Safety and Effectiveness of Nevirapine Plus Lamivudine Plus Other Anti-HIV Drugs
A Phase 3 study testing Nevirapine and Lamivudine in people with HIV Infections, run by Boehringer Ingelheim at 53 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Nevirapine and Lamivudine
- How many people
- 2,000 participants
- Where
- 53 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 32Show fewer
- 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.
Trial locations and contacts
53 sites in 1 country.
53 sites in 1 country
United States53 sites
New England Med Ctr
Boston, Massachusetts, 02111
Beth Israel Hosp / Virology Research Clinic
Boston, Massachusetts, 02215
New England Deaconess Hosp
Boston, Massachusetts, 02215
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
Med Univ of South Carolina / Div of Infect Dis
Charleston, South Carolina, 29425
Dr John Pottage
Chicago, Illinois, 60610
Northwestern Univ / Division of Infectious Diseases
Chicago, Illinois, 60611
Rush Presbyterian / Saint Luke's Med Ctr / Infect Dis
Chicago, Illinois, 60612
Infectious Disease Specialists
Colorado Springs, Colorado, 80903
Dr Alfred Burnside
Columbia, South Carolina, 29206
Nelson Tebedo Health Resource Ctr
Dallas, Texas, 75219
Denver Public Health
Denver, Colorado, 80204
Dr Miguel Mogyoros / Clinical Research Dept
Denver, Colorado, 80205
Dr Daniel H Gervich
Des Moines, Iowa, 50325
Anthony LaMarca
Fort Lauderdale, Florida, 33308
North Broward Hosp District
Fort Lauderdale, Florida, 33316
Dr Robert Schwartz
Fort Myers, Florida, 33901
McGregor Clinic / Lee County Public Health Unit
Fort Myers, Florida, 33901
Univ of Texas Med Branch / Div of Infectious Dis
Galveston, Texas, 775550835
Hampton Roads Med Specialists
Hampton, Virginia, 23666
Hershey Med Ctr / Dept of Med / Div of Hematology
Hershey, Pennsylvania, 17033
Houston Clinical Research Network / Div of Montrose Clinic
Houston, Texas, 77006
Indiana Univ Med School
Indianapolis, Indiana, 46202
Univ of Iowa
Iowa City, Iowa, 52242
Walter Gaman
Irving, Texas, 75038
P Andrew Coley
Jacksonville, Florida, 32216
Trinity Lutheran Hosp / HIV Program
Kansas City, Missouri, 64108
Univ of Kentucky Med Cntr / Dept of Med / Div of ID
Lexington, Kentucky, 40563
Dr G Michael Wool
Los Angeles, California, 90067
UCLA School of Medicine / Ctr for Research and Education
Los Angeles, California, 900951793
Goodgame Med Group
Maitland, Florida, 32751
Dr Susie Sargent
Memphis, Tennessee, 38163
International Medicine and Infectious Disease
Minneapolis, Minnesota, 55407
Drug Research and Analysis Corp
Montgomery, Alabama, 36104
Med Research Ctr
New Orleans, Louisiana, 70112
Dr David Kaufman
New York, New York, 10014
AIDS Research Ctr / Palo Alto VA Health Care System
Palo Alto, California, 94304
Univ of Pennsylvania / Division of Infectious Diseases
Philadelphia, Pennsylvania, 19104
Novum Inc
Pittsburgh, Pennsylvania, 152063817
The Research and Education Group
Portland, Oregon, 97210
Omega Med Research
Providence, Rhode Island, 02907
AIDS Community Research Consortium
Redwood City, California, 94063
ViRx Inc
San Francisco, California, 94109
San Francisco Gen Hosp / UCSF AIDS Program
San Francisco, California, 94110
Advanced Research Management
Seattle, Washington, 981225314
Infectious Disease Associates of Central New Jersey
Somerville, New Jersey, 08876
Saint Vincent Med Ctr
Staten Island, New York, 10310
Infectious Disease Research Institute Inc
Tampa, Florida, 33614
Harbor - UCLA Med Ctr
Torrance, California, 90502
Associates in Med and Mental Health
Tulsa, Oklahoma, 74114
Novum Inc
Washington D.C., District of Columbia, 20037
Palm Beach Research Ctr
West Palm Beach, Florida, 33409
Wilmington Hosp
Wilmington, Delaware, 19801
About this study
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
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.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- Nevirapine, Lamivudine
- Keywords
- Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Nevirapine, Lamivudine, Disease Progression, Reverse Transcriptase Inhibitors, Anti-HIV Agents
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NevirapineDrug
LamivudineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Enrolment
- 2,000 participants
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002368
- Sponsor's protocol ID
- 200E
- Other IDs
- 1100.1090
- Status last verified
- Aug 2002
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00002368
- Acronym / sponsor ID
- 200E
- Conditions
- HIV Infections
- Keywords
- Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Nevirapine, Lamivudine, Disease Progression, Reverse Transcriptase Inhibitors, Anti-HIV Agents
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (32 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nevirapine | Drug | – |
| Lamivudine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
53 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nevirapine and Lamivudine in people with HIV Infections, run by Boehringer Ingelheim at 53 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005; AzTrials last refreshed its copy on 8 Nov 2026.