Clinical trial NCT03394196: RESIST-2: 2nd-line ART for HIV-2 Infection
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
Overall status: TERMINATED
Phase: NA
Conditions: HIV-2 Infection
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Clinique des Maladies Infectieuses, CHNU de Fann, Dakar, Senegal
name: Centre de Sante de Ziguinchor, Casamance, Senegal
name: Janssen Pharmaceutica
name: Merck Sharp & Dohme LLC
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2018-01-09
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Eligibility criteria: 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

Primary outcomes:
measure: Death
timeFrame: up to 3 years
measure: Loss to follow up
timeFrame: 1 year
measure: Virologic Failure on 2nd line ART
timeFrame: up to 3 years
measure: HIV-2 ARV resistance on 2nd line ART
timeFrame: up to 3 years
Secondary outcomes:
measure: New WHO stage 3 or 4 event > 6 months after starting ART
timeFrame: up to 3 years
measure: Grade 3 or 4 adverse events
timeFrame: up to 3 years
measure: CD4 T-cell count trajectory
timeFrame: up to 3 year after starting 2nd-line ART
Other outcomes:
Locations:
city: Ziguinchor
country: Senegal
facility: Centre de Sante de Ziguinchor
state: Casamance
city: Dakar
country: Senegal
facility: Clinique des Maladies Infectieuses Ibrahima DIOP Mar/CRCF, Centre Hospitalier Universitaire de Fann
Study officials:
affiliation: University of Washington
name: Geoffrey S Gottlieb, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.