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RESIST-2: 2nd-line ART for HIV-2 Infection (RESIST-2)

Primary Purpose

HIV-2 Infection

Status
Terminated
Phase
Not Applicable
Locations
Senegal
Study Type
Interventional
Intervention
HIV-2 Genotypic Drug Resistance Testing using DBS
2nd line ART ( Zidovudine 300mg BID + Lamivudine 150mg BID or Tenofovir DF 300mg QD + Lamividine 300mg QD or Emtricitabine 200mg QD + Lopinavir/Ritonavir 400/100mg BID)
2nd line ART (Tenofovir DF 300mg QD + Lamividine 300mg QD or Emtricitabine 200mg QD + Lopinavir/Ritonavir 400/100mg BID + Raltegravir 400mg BID )
2nd line ART (Tenofovir DF 300mg QD + Lamividine 300mg QD or Tenofovir DF 300mg QD + Emtricitabine 200mg QD + Darunavir 600mg BID-Ritonavir 100mg BID +Raltegravir 400mg BID)
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV-2 Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. HIV-2 infection: confirmed by Determine (Alere, Inc.) & Immunocomb II (Alere, Inc.) or equivalent
  2. 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)
  3. For females of reproductive potential: negative serum or urine pregnancy test
  4. Men and women age >/=18 years
  5. Ability and willingness of subject to provide informed consent

Exclusion Criteria:

  1. HIV-1 or HIV-1/HIV-2 dual infection
  2. Pregnancy or Breast-feeding

  3. Lab Abnormalities

    • AST/ALT >2.5 X ULN
    • CrCl <30
  4. Current or previous use of Integrase Inhibitors or Darunavir

Sites / Locations

  • Centre de Sante de Ziguinchor
  • Clinique des Maladies Infectieuses Ibrahima DIOP Mar/CRCF, Centre Hospitalier Universitaire de Fann

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

No HIV-2 resistance

HIV-2 NRTI resistance only

HIV-2 NRTI and PI resistance

Arm Description

Outcomes

Primary Outcome Measures

Death
all cause mortality
Loss to follow up
no contact with study for 1 year
Virologic Failure on 2nd line ART
VL >250 copies/ml
HIV-2 ARV resistance on 2nd line ART
by DBS genotyping

Secondary Outcome Measures

New WHO stage 3 or 4 event > 6 months after starting ART
BY WHO criteria
Grade 3 or 4 adverse events
DAIDS definitions
CD4 T-cell count trajectory
delta CD4 count per year

Full Information

First Posted
December 14, 2017
Last Updated
January 20, 2021
Sponsor
University of Washington
Collaborators
Clinique des Maladies Infectieuses, CHNU de Fann, Dakar, Senegal, Centre de Sante de Ziguinchor, Casamance, Senegal, Janssen Pharmaceutica, Merck Sharp & Dohme LLC, National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT03394196
Brief Title
RESIST-2: 2nd-line ART for HIV-2 Infection
Acronym
RESIST-2
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Terminated
Why Stopped
COVID-19 and Funding
Study Start Date
July 4, 2018 (Actual)
Primary Completion Date
May 31, 2020 (Actual)
Study Completion Date
May 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
Clinique des Maladies Infectieuses, CHNU de Fann, Dakar, Senegal, Centre de Sante de Ziguinchor, Casamance, Senegal, Janssen Pharmaceutica, Merck Sharp & Dohme LLC, National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Prospective, longitudinal, open label, HIV-2 viral load and antiretroviral resistance informed 2nd-line ARV implementation study.
Detailed Description
Prospective, longitudinal, open label, HIV-2 viral load and antiretroviral resistance informed 2nd-line ARV implementation study. DURATION Up to 3 years SAMPLE SIZE 150 POPULATION HIV-2-infected adults (≥18 years old); ARV-experienced, with virologic failure on 1st-line 2NRTI+LPV/r in the ISAARV program. STRATIFICATION By ARV resistance REGIMEN OR INTERVENTION Intervention: Implement real time ARV resistance testing using rapid DBS/CS ARV Regimens: Based on ARV resistance testing No resistance: 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 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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV-2 Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
152 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No HIV-2 resistance
Arm Type
Experimental
Arm Title
HIV-2 NRTI resistance only
Arm Type
Experimental
Arm Title
HIV-2 NRTI and PI resistance
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
HIV-2 Genotypic Drug Resistance Testing using DBS
Intervention Description
Real time HIV-2 genotypic drug resistance testing using dried blood spots and consensus sequencing.
Intervention Type
Drug
Intervention Name(s)
2nd line ART ( Zidovudine 300mg BID + Lamivudine 150mg BID or Tenofovir DF 300mg QD + Lamividine 300mg QD or Emtricitabine 200mg QD + Lopinavir/Ritonavir 400/100mg BID)
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
2nd line ART (Tenofovir DF 300mg QD + Lamividine 300mg QD or Emtricitabine 200mg QD + Lopinavir/Ritonavir 400/100mg BID + Raltegravir 400mg BID )
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
2nd line ART (Tenofovir DF 300mg QD + Lamividine 300mg QD or Tenofovir DF 300mg QD + Emtricitabine 200mg QD + Darunavir 600mg BID-Ritonavir 100mg BID +Raltegravir 400mg BID)
Intervention Description
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
Primary Outcome Measure Information:
Title
Death
Description
all cause mortality
Time Frame
up to 3 years
Title
Loss to follow up
Description
no contact with study for 1 year
Time Frame
1 year
Title
Virologic Failure on 2nd line ART
Description
VL >250 copies/ml
Time Frame
up to 3 years
Title
HIV-2 ARV resistance on 2nd line ART
Description
by DBS genotyping
Time Frame
up to 3 years
Secondary Outcome Measure Information:
Title
New WHO stage 3 or 4 event > 6 months after starting ART
Description
BY WHO criteria
Time Frame
up to 3 years
Title
Grade 3 or 4 adverse events
Description
DAIDS definitions
Time Frame
up to 3 years
Title
CD4 T-cell count trajectory
Description
delta CD4 count per year
Time Frame
up to 3 year after starting 2nd-line ART

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geoffrey S Gottlieb, MD PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de Sante de Ziguinchor
City
Ziguinchor
State/Province
Casamance
Country
Senegal
Facility Name
Clinique des Maladies Infectieuses Ibrahima DIOP Mar/CRCF, Centre Hospitalier Universitaire de Fann
City
Dakar
Country
Senegal

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD shared on request with ORB approval on final cleaned dataset
IPD Sharing Time Frame
at end of study
IPD Sharing Access Criteria
IRB approval
Citations:
PubMed Identifier
34922614
Citation
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.
Results Reference
derived

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RESIST-2: 2nd-line ART for HIV-2 Infection

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