Pediatric Nevirapine Resistance Study

Conditions

AIDS, HIV Infections

Keywords

Non-nucleoside reverse transcriptase inhibitor, Drug Resistance, HIV Seronegativity, Treatment Naive

Brief 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).

Detailed 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.

Shiau S, Kuhn L, Strehlau R, Martens L, McIlleron H, Meredith S, Wiesner L, Coovadia A, Abrams EJ, Arpadi SM.

2014-02-1219 citations

10.1186/1471-2431-14-39

Switching children previously exposed to nevirapine to nevirapine-based treatment after initial suppression with a protease-inhibitor-based regimen: long-term follow-up of a randomised, open-label trial.

Kuhn L, Coovadia A, Strehlau R, Martens L, Hu CC, Meyers T, Sherman G, Hunt G, Persaud D, Morris L, Tsai WY, Abrams EJ.

2012-03-1644 citations

10.1016/s1473-3099(12)70051-8

Reuse of nevirapine in exposed HIV-infected children after protease inhibitor-based viral suppression: a randomized controlled trial.

Coovadia A, Abrams EJ, Stehlau R, Meyers T, Martens L, Sherman G, Hunt G, Hu CC, Tsai WY, Morris L, Kuhn L.

2010-09-0168 citations

10.1001/jama.2010.1278

Interventions

DRUGnevirapine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 24 Months

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame
Virologic suppression at 6 months after randomization	—

Secondary

Measure	Time frame
To compare the time to virologic failure up to 18 months post randomization	—
to examine the associations between detection of drug resistance mutation and virologic response to treatment	—
to compare the toxicity profiles and adherence in the two groups	—
to describe the emergence of genotypic resistance in the two groups	—

Countries

South Africa

Outcome results

None listed