An Open-Label, Non-Randomized Trial to Evaluate the Tolerability and Safety of Viramune (Nevirapine) in Adult and Pediatric Patients With Progressive HIV Disease
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: August 2002
History of Changes
To provide access to Viramune and to evaluate the tolerance and safety of Viramune in patients with progressive, symptomatic HIV disease who failed or are intolerant to currently approved treatment for HIV-1 infection and who are unable to participate in another Viramune controlled clinical trial and have a compelling need for anti-HIV treatment.
Drug : Nevirapine
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||An Open-Label, Non-Randomized Trial to Evaluate the Tolerability and Safety of Viramune (Nevirapine) in Adult and Pediatric Patients With Progressive HIV Disease|
Further study details as provided by NIH AIDS Clinical Trials Information Service:
Eligible adult patients (>= 13 years of age) will receive treatment with Viramune once daily
for 2 weeks and then twice daily. Eligible pediatric patients (< 13 years of age) will
receive a lower dose of Viramune once daily for 2 weeks and then twice daily. All patients
will receive Viramune with or without concomitant antiretroviral therapy. Patients will be
evaluated at weeks 2, 4, 8, 16, 24, 32 and every 8 weeks thereafter.
PER AMENDMENT 01/31/97: Enrollment closed to adult patients. As of 1/31/97 only enrolling pediatric patients.
|Ages Eligible for Study:||Child, Adult, Senior|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Patients must have:
- Patients > 18 months of age with history of positive serology for HIV-1 infection or patients <= 18 months of age with history of positive viral culture, detectable p24 antigen, or positive peripheral blood mononuclear cell macro culture.
- Patients >= 13 years of age with a CD4+ cell count <= 200 cells/mm3. Patients < 13 years of age with a CD4% <= 14% or a 50% decrease in CD4% in the past 6 months if the previous CD4% was >=20%.
- Patient has failed or is intolerant to currently approved treatments for HIV-1 infection and is unable to participate in a controlled viramune clinical trial.
- Written and informed consent from a parent or guardian for patients < 18 years of age.
- Patient or guardian is willing and able to follow protocol requirements. (PER AMENDMENT 1/29/97:
- Enrollment is closed to adults, as of Jan. 29th only pediatric patients will be enrolled.)
- Dicumarol, Warfarin, and other anticoagulant medications.
- Investigational drugs, all protease inhibitors, and all other non-nucleoside transcriptase inhibitors.
- Neurotoxic drugs.
Patients with the following symptoms and conditions are excluded:
Patient qualifies for participation in an actively accruing Viramune controlled clinical trial.
Patient has failed or is intolerant to currently approved treatments for HIV-1 infection.
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002166
Locations Show More
|United States, Connecticut|
|Boehringer Ingelheim Pharmaceuticals Inc|
|Ridgefield, Connecticut, United States, 06877|
Sponsors and CollaboratorsBoehringer Ingelheim
|Responsible Party:||Boehringer Ingelheim|
|ClinicalTrials.gov Identifier:||NCT00002166 History of Changes|
|Other Study ID Numbers:||200D|
|Study First Received:||November 2, 1999|
|Last Updated:||June 23, 2005|
Keywords provided by NIH AIDS Clinical Trials Information Service:Nevirapine
Reverse Transcriptase Inhibitors
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
ClinicalTrials.gov processed this data on January 28, 2020
This information is provided by ClinicalTrials.gov.