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| ID | Type | Description | Link |
|---|---|---|---|
| R01AI120765 | U.S. NIH Grant/Contract | View source |
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COVID-19 and Funding
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| Name | Class |
|---|---|
| Clinique des Maladies Infectieuses, CHNU de Fann, Dakar, Senegal | UNKNOWN |
| Centre de Sante de Ziguinchor, Casamance, Senegal | UNKNOWN |
| Janssen Pharmaceutica | INDUSTRY |
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Prospective, longitudinal, open label, HIV-2 viral load and antiretroviral resistance informed 2nd-line ARV implementation study.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No HIV-2 resistance | Experimental |
| |
| HIV-2 NRTI resistance only | Experimental |
| |
| HIV-2 NRTI and PI resistance | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIV-2 Genotypic Drug Resistance Testing using DBS | Diagnostic Test | Real time HIV-2 genotypic drug resistance testing using dried blood spots and consensus sequencing. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| New WHO stage 3 or 4 event > 6 months after starting ART | BY WHO criteria | up to 3 years |
| Grade 3 or 4 adverse events | DAIDS definitions |
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Inclusion Criteria:
Exclusion Criteria:
HIV-1 or HIV-1/HIV-2 dual infection
Pregnancy or Breast-feeding
Lab Abnormalities
Current or previous use of Integrase Inhibitors or Darunavir
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| Name | Affiliation | Role |
|---|---|---|
| Geoffrey S Gottlieb, MD PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de Sante de Ziguinchor | Ziguinchor | Casamance | Senegal | |||
| Clinique des Maladies Infectieuses Ibrahima DIOP Mar/CRCF, Centre Hospitalier Universitaire de Fann |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34922614 | Derived | 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. |
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IPD shared on request with ORB approval on final cleaned dataset
at end of study
IRB approval
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| Merck Sharp & Dohme LLC |
| INDUSTRY |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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| 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) | Drug | 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 ) | Drug | 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) | Drug | 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 |
|
| up to 3 years |
| CD4 T-cell count trajectory | delta CD4 count per year | up to 3 year after starting 2nd-line ART |
| Dakar |
| Senegal |
| ID | Term |
|---|---|
| D015215 | Zidovudine |
| C494814 | BID protein, human |
| D019259 | Lamivudine |
| D000068698 | Tenofovir |
| D000068679 | Emtricitabine |
| D061466 | Lopinavir |
| D019438 | Ritonavir |
| D000068898 | Raltegravir Potassium |
| D000069454 | Darunavir |
| ID | Term |
|---|---|
| D013936 | Thymidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015224 | Dideoxynucleosides |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011744 | Pyrimidinones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D013450 | Sulfones |
| D005663 | Furans |
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