A Study of Nevirapine Used Alone or in Combination With AZT in HIV-1-Infected Children
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ClinicalTrials.gov Identifier: NCT00001111 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: March 1, 2011
|
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Monotherapy phase: To evaluate and compare the safety, tolerance, pharmacokinetics, and preliminary activity of nevirapine administered alone in mildly to moderately symptomatic HIV-infected children ages 2 months to less than 18 years; to evaluate and compare the safety, tolerance, and pharmacokinetics of nevirapine in HIV-infected children ages 1 day to less than 2 months. Combination therapy phase: To evaluate and compare the safety, tolerance, pharmacokinetics, and preliminary activity of nevirapine administered in combination with zidovudine (AZT) in mildly to moderately symptomatic HIV-infected children ages 2 months to less than 18 years.
Compounds with reverse transcriptase inhibitory activity that are more potent and less toxic than the nucleoside analogues are needed. Nevirapine (BI-RG-587) has shown in vitro inhibitory activity against HIV-1reverse transcriptase and has shown a synergistic inhibition of HIV-1 replication when combined with zidovudine (AZT) in a plaque reduction assay.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Nevirapine Drug: Zidovudine | Not Applicable |
Compounds with reverse transcriptase inhibitory activity that are more potent and less toxic than the nucleoside analogues are needed. Nevirapine (BI-RG-587) has shown in vitro inhibitory activity against HIV-1 reverse transcriptase and has shown a synergistic inhibition of HIV-1 replication when combined with zidovudine (AZT) in a plaque reduction assay.
Sixty mildly to moderately symptomatic HIV-infected children (five patients in each of four age groups) will receive oral nevirapine at 1 of 3 doses for 168 days. If preliminary activity is demonstrated and toxicity is acceptable after 84 days of treatment in the three oldest age groups (ages 2 months - less than 2 years, ages 2 years - less than 13 years, and ages 13 years - less than 18 years), children ages 1 day - less than 2 months will receive one of the three doses of nevirapine. Additionally, 15 additional patients (five in each of three age groups) will receive zidovudine in combination with nevirapine. At the end of 24 weeks of combination therapy, patients discontinue zidovudine for 2 weeks while remaining on nevirapine, in order for pharmacokinetic sampling to be done. Children will be enrolled sequentially by decreasing age and increasing nevirapine dose.
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 35 participants |
Primary Purpose: | Treatment |
Official Title: | Pharmacokinetics, Safety, Tolerance, and Activity of Nevirapine (BI-RG-587) Alone and in Combination With AZT in Mildly to Moderately Symptomatic HIV-1 Infected Children |
Actual Primary Completion Date : | June 1995 |


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Ages Eligible for Study: | up to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
- IV gammaglobulin therapy.
- Medications for PCP prophylaxis (e.g., TMP / SMX, dapsone, aerosolized and IV pentamidine).
- Fluconazole.
Patients must have:
- HIV infection. A positive Polymerase Chain Reaction (PCR) is not acceptable as the sole evidence of HIV infection. Three out of five children in each age and dose group must have a serum p24 antigen level of 70 pg/ml or greater and/or a plasma viral titer of 50 TCID/ml or greater prior to study entry.
- Ability to be followed by their original trial center for the duration of the trial.
- Consent of parent or guardian.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
- Lymphocytic interstitial pneumonitis if steroid-dependent or requiring supplemental oxygen or with a pretreatment paO2 < 70 mm Hg.
- Opportunistic or serious bacterial infections within 28 days prior to entry.
- Demonstrated intolerance to zidovudine prior to administration of nevirapine (in patients enrolled in the combination therapy phase of the study).
- CDC classification of P-2D (secondary infectious diseases) and/or P-2E (secondary cancers).
- Pre-existing malignancies.
Concurrent Medication:
Excluded:
- Other approved or investigational antiretroviral agents.
- All other investigational agents (except fluconazole).
- Glucocorticoids and steroid hormones.
- Dicumarol, warfarin, and other anticoagulants.
- Digitoxin.
- Valproic acid.
- Tolbutamide.
- Doxycycline.
- Chloramphenicol.
- Isoniazid.
- Phenobarbital and other barbiturates.
- Hepatotoxic drugs.
Patients with prior participation in this trial are excluded.
Prior Medication:
Excluded:
- More than 6 weeks of prior zidovudine (AZT) therapy or more than 6 weeks of any other antiretroviral therapy.
Excluded within 7 days prior to study entry:
- AZT (in monotherapy groups only).
Excluded within 4 weeks prior to study entry:
- Other approved or investigational antiretroviral agents.
- All other investigational agents.
- Glucocorticoids and steroid hormones.
- Dicumarol, warfarin, and other anticoagulants.
- Digitoxin.
- Valproic acid.
- Tolbutamide.
- Doxycycline.
- Chloramphenicol.
- Isoniazid.
- Phenobarbital and other barbiturates. Active alcohol or drug abuse to impair compliance with the protocol.

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): NCT00001111
United States, California | |
Univ of Southern California / LA County USC Med Ctr | |
Los Angeles, California, United States, 900331079 | |
UCLA Med Ctr / Pediatrics | |
Los Angeles, California, United States, 90095 | |
United States, Connecticut | |
Univ of Connecticut Health Ctr / Pediatrics | |
Farmington, Connecticut, United States, 06032 | |
United States, Florida | |
Univ of Miami (Pediatric) | |
Miami, Florida, United States, 33161 | |
United States, Massachusetts | |
Baystate Med Ctr of Springfield | |
Springfield, Massachusetts, United States, 01199 | |
Univ of Massachusetts Med Ctr / Biotech II | |
Worcester, Massachusetts, United States, 01605 | |
United States, New Jersey | |
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl | |
Newark, New Jersey, United States, 071072198 |
Study Chair: | J Sullivan | ||
Study Chair: | K Luzuriaga |
Publications:
ClinicalTrials.gov Identifier: | NCT00001111 History of Changes |
Other Study ID Numbers: |
ACTG 180 882 |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | March 1, 2011 |
Last Verified: | February 2011 |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Drug Therapy, Combination Acquired Immunodeficiency Syndrome AIDS-Related Complex |
Antiviral Agents Zidovudine Nevirapine |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Zidovudine Nevirapine |
Antimetabolites Molecular Mechanisms of Pharmacological Action Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents Cytochrome P-450 CYP3A Inducers Cytochrome P-450 Enzyme Inducers |