Status:

COMPLETED

Safety, Tolerability, and Anti-HIV Activity of DMP 266 (Efavirenz) in Combination With Nelfinavir in HIV-Positive Children

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborating Sponsors:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Conditions:

HIV Infections

Eligibility:

All Genders

3-16 years

Phase:

PHASE1

Brief Summary

Cohort I: The purpose of this study is to see how safe it is to combine 2 anti-HIV medications, efavirenz (EFZ) and nelfinavir (NFV) to treat HIV-positive children and to find an appropriate dose of E...

Detailed Description

The demonstrated antiviral activity, tolerability, and pharmacokinetic properties of DMP 266 and its utility in combination with other agents make DMP 266 an attractive agent for use in HIV-infected p...

Eligibility Criteria

Inclusion Criteria

Children may be eligible for this study if they:

  • Are HIV-positive.
  • Are between 3 months and 16 years old (consent of parent or legal guardian required). (These age requirements reflect a change.)
  • Have a plasma viral load of at least 400 copies/ml at screening.
  • Agree to practice abstinence or use effective methods of birth control during the study.
  • Are able to take oral medication and comply with study requirements.
  • Are taking at least 1 nucleoside reverse transcriptase inhibitor (NRTI), such as zidovudine (ZDV) or stavudine (d4T). Patients can begin taking NRTIs at the beginning of the study.

Exclusion Criteria

Children will not be eligible for this study if they:

  • Have had more than 2 episodes of moderate to severe diarrhea or vomiting lasting more than 4 days within 3 months prior to study entry.
  • Are allergic to EFZ or NFV.
  • Have any disease, including hepatitis, cancer, or an active opportunistic (HIV-associated) infection.
  • Are pregnant or breast-feeding.
  • Are taking any other experimental drugs or certain medications.
  • Have ever taken protease inhibitors (PIs) or nonnucleoside reverse transcriptase inhibitors (NNRTIs).

Key Trial Info

Start Date :

October 1 1997

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2002

Estimated Enrollment :

103 Patients enrolled

Trial Details

Trial ID

NCT00000893

Start Date

October 1 1997

End Date

December 1 2002

Last Update

October 29 2021

Active Locations (27)

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Page 1 of 7 (27 locations)

1

Long Beach Memorial Med. Ctr., Miller Children's Hosp.

Long Beach, California, United States, 90801

2

UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS

Los Angeles, California, United States

3

Usc La Nichd Crs

Los Angeles, California, United States

4

Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.

Oakland, California, United States