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

HIV-2 Infection Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03394196
• Other study ID #: STUDY00000228
• Secondary ID: R01AI120765
• Status: Terminated
• Phase: N/A
• Start date: July 4, 2018
• Est. completion date: May 31, 2020

Study information

• Verified date: January 2021
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective, longitudinal, open label, HIV-2 viral load and antiretroviral resistance informed 2nd-line ARV implementation study.

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 1. 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 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 152
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV-2 Infection
• Infection

Intervention

Diagnostic Test:
• HIV-2 Genotypic Drug Resistance Testing using DBS
Real time HIV-2 genotypic drug resistance testing using dried blood spots and consensus sequencing.

Drug:
• 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)
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
• 2nd line ART (Tenofovir DF 300mg QD + Lamividine 300mg QD or Emtricitabine 200mg QD + Lopinavir/Ritonavir 400/100mg BID + Raltegravir 400mg BID )
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
• 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)
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

Locations

Country	Name	City	State
Senegal	Clinique des Maladies Infectieuses Ibrahima DIOP Mar/CRCF, Centre Hospitalier Universitaire de Fann	Dakar
Senegal	Centre de Sante de Ziguinchor	Ziguinchor	Casamance

Sponsors (6)

Lead Sponsor	Collaborator
University of Washington	Centre de Sante de Ziguinchor, Casamance, Senegal, Clinique des Maladies Infectieuses, CHNU de Fann, Dakar, Senegal, Janssen Pharmaceutica, Merck Sharp & Dohme Corp., National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

Senegal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death	all cause mortality	up to 3 years
Primary	Loss to follow up	no contact with study for 1 year	1 year
Primary	Virologic Failure on 2nd line ART	VL >250 copies/ml	up to 3 years
Primary	HIV-2 ARV resistance on 2nd line ART	by DBS genotyping	up to 3 years
Secondary	New WHO stage 3 or 4 event > 6 months after starting ART	BY WHO criteria	up to 3 years
Secondary	Grade 3 or 4 adverse events	DAIDS definitions	up to 3 years
Secondary	CD4 T-cell count trajectory	delta CD4 count per year	up to 3 year after starting 2nd-line ART