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HIV PositiveOLANCT01898754

Oligonucleotide Ligation Assay (OLA) Resistance Study

A study testing Pre-ART Oligonucleotide Assay (OLA) in people with HIV Positive, run by University of Washington at 2 sites in Kenya.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 2 years and older
Conditions the study is for
HIV Positive
What is being tested?
Pre-ART Oligonucleotide Assay (OLA)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
991 participants
Where
2 sitesKenya
Study dates
May 2013to Feb 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Received ART previously from Hope Center
  • Ongoing ART
  • Plan to start 2nd-line ART

Trial locations and contacts

2 sites in 1 country.

Kenya2 sites

  • Coptic Hospital

    Maseno

  • Coptic Hospital

    Nairobi

Other trials in Kenya

About this study

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

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.

Read the 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
Being tested
Pre-ART Oligonucleotide Assay (OLA)
Keywords
Transmitted Drug Resistance
Medical subject headings
HIV Seropositivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pre-ART Oligonucleotide Assay (OLA)Other

    Also called Pre-ART OLA

    Block randomization (1:1) to pre-ART OLA testing or OLA testing after 12mo on ART

Study groups in NCT01898754
Study groupRoleWhat they receive
Pre-ART Oligonucleotide Assay (OLA)ExperimentalPre-ART OLA will be tested for resistance at 5 pol codons conferring high-level resistance to NNRTI and 3TC (K103N, V106M, Y181C, G190A and M184V)
Receives: Other: Pre-ART Oligonucleotide Assay (OLA)
No OLA (Standard of Care [SOC])No interventionThe participants will receive standard of care as per Kenya guidelines but will be offered OLA resistance testing after 12 months

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Virologic Failure With OLA-guided ART vs. Standard of Care

    The primary endpoint will be a comparison of the rates of viral non-suppression >400 copies/mL between study arms at 12 months

    Measured: 12 months

Secondary outcomes (7)

  1. The Difference in Virologic Failure Among Participants With Transmitted Drug-resistance (TDR) ≥10% Associated With Use of OLA-guided ART vs. SOC

    We did not analyze and report outcome of people with TDR ≥10%, instead we reported pretreatment drug resistance (PDR) as this parameter could be determined but antiretroviral history was not reliably available. Thus, PDR ≥10% is considered below in place of TDR ≥10%.

    Chung et al. Lancet HIV 2020; 7: e104-12.

    Measured: 15 months

  2. Difference in Virologic Failure in the Subgroup of Participants With Prior or Ongoing ART Use Associated With Use of OLA-guided ART vs. SOC

    The primary outcome was virologic failure defined as plasma HIV RNA of at least 400 copies per mL after initiation of antiretroviral therapy (ART).

    Measured: 15 months

  3. Prevalence of TDR by Consensus Sequencing and OLA

    We did not analyze and report outcome of people with TDR, instead we reported pretreatment drug resistance (PDR) as this parameter could be determined but antiretroviral history was not reliably available. Thus, PDR is considered below in place of TDR. PDR was assessed by OLA and confirmed by consensus sequence or next-generation sequencing.

    Measured: 15 months

  4. Proportion of Subgroup With TDR With Virologic Failure by Randomization Arm

    We did not analyze and report outcome of people with TDR, instead we reported pretreatment drug resistance (PDR) as this parameter could be determined but antiretroviral history was not reliably available. Thus, PDR is considered below in place of TDR. The primary outcome for this analysis was the difference in virologic failure, defined as plasma HIV-1 RNA of at least 400 copies per mL following ART initiation, by PDR. [Chung et al. Lancet HIV 2020; 7: e104-12]

    Measured: 15 months

  5. Estimates of Medical Resource Utilization During the One-year Trial Period

    Estimates of medical resource utilization during was not calculated. No data available (data on medical resource utilization was not collected during the one-year trial)

    Measured: 15 months

  6. An Assessment of the Potential Long-term Cost-effectiveness of OLA-guided Testing Over a Patient's Lifetime

    This was not calculated as the model could not test for a period longer than 15 years due to computing limitations.

    Measured: 15 months

  7. Determination of Whether Low-level ARV Resistance (<5%) Detected by PYRO But Not by OLA is Associated With Virologic Failure

    The prespecified outcomes of this study included differences in the rate of virologic failure over 24 months of efavirenz-based ART between participants by frequency of drug-resistant variants detected by next-generation sequencing at enrollment. Drug-resistance frequency was defined as the proportion of a nucleotide variant encoding a drug-resistant codon in specimens with at least 100 viral templates sequenced. Virologic failure was defined as plasma HIV RNA of at least 400 copies/ml in sequential specimens or at the final study visit in participants prescribed efavirenz-based ART. [Milne et al. AIDS 2022 Nov 15;36(14):1949-1958]

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2013 (estimated)
  2. Study startMay 2013
  3. Primary completionDec 2016
  4. Study completionFeb 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
991 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01898754
Sponsor's protocol ID
14124-SCH
Acronym
OLA
Status last verified
Mar 2025
First submitted
9 Jul 2013
Last updated
12 Mar 2025
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Chung MH, McGrath CJ, Beck IA, Levine M, Milne RS, So I, Andersen N, Dross S, Coombs RW, Chohan B, Yatich N, Kiptinness C, Sakr SR, Kiarie JN, Frenkel LM. Evaluation of the management of pretreatment HIV drug resistance by oligonucleotide ligation assay: a randomised controlled trial. Lancet HIV. 2020 Feb;7(2):e104-e112. doi: 10.1016/S2352-3018(19)30337-6. Epub 2019 Dec 7.

    PubMed 31818716

  • Silverman RA, Beck IA, Kiptinness C, Levine M, Milne R, McGrath CJ, Bii S, Richardson BA, John-Stewart G, Chohan B, Sakr SR, Kiarie JN, Frenkel LM, Chung MH. Prevalence of Pre-antiretroviral-Treatment Drug Resistance by Gender, Age, and Other Factors in HIV-Infected Individuals Initiating Therapy in Kenya, 2013-2014. J Infect Dis. 2017 Dec 19;216(12):1569-1578. doi: 10.1093/infdis/jix544.

    PubMed 29040633

Questions about this trial

What is this clinical trial studying?

A study testing Pre-ART Oligonucleotide Assay (OLA) in people with HIV Positive, run by University of Washington at 2 sites in Kenya.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Virologic Failure With OLA-guided ART vs. Standard of Care (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01898754, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.

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