Study Stopped
COVID-19 and Funding
RESIST-2: 2nd-line ART for HIV-2 Infection
RESIST-2
Implementation and Evaluation of an HIV-2 Viral Load and ARV Resistance Informed Algorithm for 2nd-line ART in HIV-2 Infected Patients in the Initiative Sénégalaise d'Accès Aux Antirétroviraux (ISAARV) Program
2 other identifiers
interventional
152
1 country
2
Brief Summary
Prospective, longitudinal, open label, HIV-2 viral load and antiretroviral resistance informed 2nd-line ARV implementation study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2018
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 14, 2017
CompletedFirst Posted
Study publicly available on registry
January 9, 2018
CompletedStudy Start
First participant enrolled
July 4, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2020
CompletedJanuary 25, 2021
January 1, 2021
1.9 years
December 14, 2017
January 20, 2021
Conditions
Outcome Measures
Primary Outcomes (4)
Death
all cause mortality
up to 3 years
Loss to follow up
no contact with study for 1 year
1 year
Virologic Failure on 2nd line ART
VL \>250 copies/ml
up to 3 years
HIV-2 ARV resistance on 2nd line ART
by DBS genotyping
up to 3 years
Secondary Outcomes (3)
New WHO stage 3 or 4 event > 6 months after starting ART
up to 3 years
Grade 3 or 4 adverse events
up to 3 years
CD4 T-cell count trajectory
up to 3 year after starting 2nd-line ART
Study Arms (3)
No HIV-2 resistance
EXPERIMENTALHIV-2 NRTI resistance only
EXPERIMENTALHIV-2 NRTI and PI resistance
EXPERIMENTALInterventions
Real time HIV-2 genotypic drug resistance testing using dried blood spots and consensus sequencing.
1\. No resistance: Continue Current ART: Zidovudine 300mg BID + Lamivudine 150mg BID or Tenofovir DF 300mg QD + Lamividine 300mg QD or Emtricitabine 200mg QD + Lopinavir/Ritonavir 400/100mg BID (AZT/3TC or TDF/3TC or TDF/FTC + LPV/r) + Enhanced Adherence Counseling
2\. NRTI resistance only: Tenofovir DF 300mg QD + Lamividine 300mg QD or Emtricitabine 200mg QD + Lopinavir/Ritonavir 400/100mg BID + Raltegravir 400mg BID (TDF/FTC or TDF/3TC + LPV/r + RAL) + Enhanced Adherence Counseling
3\. NRTI-PI resistance: Tenofovir DF 300mg QD + Lamividine 300mg QD or Tenofovir DF 300mg QD + Emtricitabine 200mg QD + Darunavir 600mg BID-Ritonavir 100mg BID +Raltegravir 400mg BID (TDF/FTC or TDF/3TC +DRV/r2 + RAL) + Enhanced Adherence Counseling
Eligibility Criteria
You may qualify if:
- HIV-2 infection: confirmed by Determine (Alere, Inc.) \& Immunocomb II (Alere, Inc.) or equivalent
- Failing 1st line antiretroviral therapy (e.g. AZT/3TC or TDF/XTC + LPV/r; previous 3 NRTI or 2 NRTI regimens; previous Indinavir (IDV) use, current or previous Atazanavir (ATV) use; previous NNRTI use)
- For females of reproductive potential: negative serum or urine pregnancy test
- Men and women age \>/=18 years
- Ability and willingness of subject to provide informed consent
You may not qualify if:
- HIV-1 or HIV-1/HIV-2 dual infection
- Pregnancy or Breast-feeding
- Lab Abnormalities
- AST/ALT \>2.5 X ULN
- CrCl \<30
- Current or previous use of Integrase Inhibitors or Darunavir
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Washingtonlead
- Clinique des Maladies Infectieuses, CHNU de Fann, Dakar, Senegalcollaborator
- Centre de Sante de Ziguinchor, Casamance, Senegalcollaborator
- Janssen Pharmaceuticacollaborator
- Merck Sharp & Dohme LLCcollaborator
- National Institute of Allergy and Infectious Diseases (NIAID)collaborator
Study Sites (2)
Centre de Sante de Ziguinchor
Ziguinchor, Casamance, Senegal
Clinique des Maladies Infectieuses Ibrahima DIOP Mar/CRCF, Centre Hospitalier Universitaire de Fann
Dakar, Senegal
Related Publications (1)
Raugi DN, Diallo K, Diallo MB, Faye D, Cisse O, Smith RA, Sall F, Sall EHI, Faye K, Diatta JP, Diaw B, Sambou J, Malomar JJ, Hawes SE, Seydi M, Gottlieb GS; University of Washington-Senegal HIV-2 Study Group. Resource and infrastructure challenges on the RESIST-2 Trial: an implementation study of drug resistance genotype-based algorithmic ART switches in HIV-2-infected adults in Senegal. Trials. 2021 Dec 18;22(1):931. doi: 10.1186/s13063-021-05902-5.
PMID: 34922614DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Geoffrey S Gottlieb, MD PhD
University of Washington
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 14, 2017
First Posted
January 9, 2018
Study Start
July 4, 2018
Primary Completion
May 31, 2020
Study Completion
May 31, 2020
Last Updated
January 25, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- at end of study
- Access Criteria
- IRB approval
IPD shared on request with ORB approval on final cleaned dataset