NCT01898754

Oligonucleotide Ligation Assay (OLA) Resistance Study

Drug-resistance Testing in Kenya to Improve ART Suppression of HIV Replication

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 991 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

The investigators propose to gauge improvements in the rate of durable suppression of viral replication by ART when OLA is used to guide clinical decisions at the PEPFAR Coptic Hope Center in Kenya, and to determine the cost-effectiveness of implementing this strategy at Coptic Hope Center.

Detailed description

Durable suppression of HIV replication is critical to (1) improving the health of infected individuals, (2) to reducing HIV transmission to sexual partners and from mothers to their infants, and (3) to maintaining the effectiveness of the current 1st-line non-nucleoside reverse transcriptase inhibitors (NNRTI)- based ART. Across multiple trials, individuals with NNRTI-resistance, even at low-concentrations, have substantially greater virologic failure when treated with NVP- vs PI-ART. A cost-effective strategy is needed to detect and manage ARV-resistant HIV infections. A simple low-cost innovative assay the investigators developed and successfully transferred to Asian and African countries (oligonucleotide ligation assay (OLA)) can detect NNRTI+lamivudine (3TC) resistant HIV using reagents that costs \<$7.00/person. Furthermore, detection of NNRTI-resistance by OLA is highly (P\<0.001) associated with virologic failure of nevirapine (NVP)-ART in two retrospective studies; one of Thai women who had been previously randomized to single-dose NVP and the second of ARV-naïve Kenyan adults. The investigators hypothesize that implementation of OLA into routine care will allow Kenyan clinicians to appropriately target protease inhibitor (PI)-based ART and improve rates of durable suppression of viral replication, and thus improve CD4 cell gains and individuals' health, reduce the transmission of ARV-resistant HIV within the community, and maintain the utility of NNRTI-ART. In addition, the investigators hypothesize that programmatically OLA-guided ART will be more cost-efficient compared to the current strategy of empiric use of NNRTI-ART as initial treatment.

Conditions

• HIV Positive

Interventions

Type	Name	Description
OTHER	Pre-ART Oligonucleotide Assay (OLA)	Block randomization (1:1) to pre-ART OLA testing or OLA testing after 12mo on ART

Timeline

• Start date: 2013-05-01
• Primary completion: 2016-12-01
• Completion: 2017-02-01
• First posted: 2013-07-12
• Last updated: 2025-03-12
• Results posted: 2021-11-17

Locations

2 sites across 1 country: Kenya