N/A
Completed N=991
Oligonucleotide Ligation Assay (OLA) Resistance Study
HIV Positive
Source: ClinicalTrials.gov NCT01898754 ↗
Enrolled (actual)
991
Serious AEs
7.4%
Results posted
Nov 2021
Primary outcomePrimary: Number of Participants With Virologic Failure With OLA-guided ART vs. Standard of Care — 34; 39 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Virologic Failure With OLA-guided ART vs. Standard of Care |
34; 39 | — |
| SECONDARY The Difference in Virologic Failure Among Participants With Transmitted Drug-resistance (TDR) ≥10% Associated With Use of OLA-guided ART vs. SOC |
5; 13; 30; 13 | — |
| SECONDARY Difference in Virologic Failure in the Subgroup of Participants With Prior or Ongoing ART Use Associated With Use of OLA-guided ART vs. SOC |
1; 1; 31; 31 | — |
| SECONDARY Prevalence of TDR by Consensus Sequencing and OLA |
51; 42; 441; 453 | — |
| SECONDARY Proportion of Subgroup With TDR With Virologic Failure by Randomization Arm |
5; 13; 30; 13 | — |
| SECONDARY Estimates of Medical Resource Utilization During the One-year Trial Period |
— | — |
| SECONDARY An Assessment of the Potential Long-term Cost-effectiveness of OLA-guided Testing Over a Patient's Lifetime |
— | — |
| SECONDARY Determination of Whether Low-level ARV Resistance (<5%) Detected by PYRO But Not by OLA is Associated With Virologic Failure |
301; 20; 10; 5; 11; 5 | — |
Eligibility Criteria
Inclusion Criteria
- Confirmed HIV infection
- >2 years of age
- Qualifying for 1st-line ART based on Kenyan Guidelines
- Plan to reside in area for >1 year
- Adult patient or parent of minor agrees to study and provides informed consent
Exclusion Criteria
- Received ART previously from Hope Center
- Ongoing ART
- Plan to start 2nd-line ART
Data sourced from ClinicalTrials.gov (NCT01898754). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.