Pediatric Nevirapine Resistance Study

HIV Infections Clinical Trial

Official title:

Clinical Relevance of Nevirapine Resistance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00117728
• Other study ID #: 5R01HD047177
• Status: Recruiting
• Phase: Phase 3
• First received: July 6, 2005
• Last updated: June 28, 2007
• Start date: April 2005
• Est. completion date: September 2010

Study information

• Verified date: January 2006
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This study is designed to test if a sequential protease-inhibitor (PI) - / nevirapine (NVP) -based regimen is effective for the treatment of HIV-infected children when previous NVP exposure has occurred as part of programs to prevent mother-to-child transmission (pMTCT).

Description:

The wide use of NVP in pMTCT-prophylaxis may result in resistance to NNRTI and concomitantly limits the use of these drugs for the treatment of HIV-infected children. To avoid restricting treatment options for children, it is desirable to preserve NVP for both pMTCT and first line treatment. This study will therefore test whether resistance-caused treatment failures of HIV-infected and previously NVP-exposed children can be avoided if the NVP treatment is preceded by an initial PI-based regimen.

Comparison: HIV-infected children less than 24 months of age, exposed to any pMTCT regimen that included NVP and who achieve and maintain viral suppression for at least 3 months with a PI-based regimen will be randomized to one of the two groups: (1) to continue on PI-containing regimen or (2) to be switched off the PI-containing regimen onto the NVP-containing regimen. The study outcome will be proportions in the two groups who have complete virologic suppression at 6 months after randomization.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 24 Months

Eligibility

Inclusion Criteria:

• NVP-exposure as part of pMTCT-prophylaxis around delivery

• HIV-positive

• Eligible for treatment

• Plans to stay in the area for the next 6 months

Exclusion Criteria:

• Already on anti-retroviral treatment

• History of toxicity to perinatal NVP

• Grade 3 or greater elevation of liver function tests

• Being treated for a severe acute opportunistic infection or tumor

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• AIDS
• HIV Infections

Intervention

Drug:
• nevirapine

Locations

Country	Name	City	State
South Africa	Coronation Hospital	Johannesburg

Sponsors (3)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Columbia University, University of Witwatersrand, South Africa

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Virologic suppression at 6 months after randomization
Secondary	To compare the time to virologic failure up to 18 months post randomization
Secondary	to examine the associations between detection of drug resistance mutation and virologic response to treatment
Secondary	to compare the toxicity profiles and adherence in the two groups
Secondary	to describe the emergence of genotypic resistance in the two groups