The Safety and Effectiveness of Nevirapine Plus Lamivudine Plus Other Anti-HIV Drugs
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|ClinicalTrials.gov Identifier: NCT00002368|
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
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|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: Nevirapine Drug: Lamivudine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||2000 participants|
|Intervention Model:||Parallel Assignment|
|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|
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|Ages Eligible for Study:||13 Years and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
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.
- 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.
- Dicumarol, Warfarin and other anticoagulant medications.
- Investigational drugs (unless included in opportunistic infection clinical trial) and all antiretroviral agents (excluding ZDV, ddC, ddI, d4T and 3TC).
- Neurotoxic drugs.
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.
- 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.
Patients who are active chronic alcohol or substance abusers or have an active psychiatric condition sufficient to impair compliance with protocol requirements.
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.
- If patient is ZDV intolerant, ddC, ddI or D4T monotherapy is allowed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002368
|Other Study ID Numbers:||
|First Posted:||August 31, 2001 Key Record Dates|
|Last Update Posted:||June 24, 2005|
|Last Verified:||August 2002|
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
Reverse Transcriptase Inhibitors
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
RNA Virus Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers