SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT00279110

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

Directly Administered vs. Self-administered Antiretroviral Therapy in Methadone Clinics

The purpose of this study is to determine whether providing directly administered antiretroviral therapy to HIV-infected who receive methadone therapy leads to better treatment outcomes than if they take HIV medications on their own.

NCT00279110 HIV Infections Heroin Dependence
MeSH: HIV Infections Heroin Dependence

1 Interventions

Name: Directly administered antiretroviral therapy (DAART)

Description: Participants are observed taking HIV medications on days when they receive opioid agonist therapy.

Type: Behavioral

A


Primary Outcomes

Measure: HIV RNA < 50 c/mL

Time: 12 months

Secondary Outcomes

Measure: Log10 change in HIV RNA from baseline

Time: 12 months

Measure: HIV RNA < 50 c/mL 6 mos. after intervention

Time: 18 months

Measure: Log10 change in HIV RNA from baseline 6 months post intervention

Time: 18 months

Measure: Change in CD4 cell count from baseline

Time: 18 months

Measure: ART utilization

Time: 12 months

Measure: Development of antiretroviral resistance

Time: 12 months

Measure: Retention to substance abuse treatment

Time: 12 months

Measure: Urine drug screen positivity in follow-up

Time: 12 months

Measure: Electronically monitored adherence

Time: 2 months

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There are 3 SNPs

SNPs


1 K103N

Current plasma HIV RNA > 500 copies/ml 7. Initiating ART for first time, reinitiating therapy after stopping, or changing therapy due to virologic failure 8. ART with at least 3 agents, including a protease inhibitor, a non-nucleoside reverse transcriptase inhibitor, or abacavir 9. Methadone or buprenorphine maintenance therapy > 3 weeks, with no planned detoxification Exclusion Criteria: 1. Need to use ART dosed more frequently than twice daily, 2. Need to use a liquid preparation of antiretroviral medication, 3. Documented triple-class antiretroviral resistance (defined below), 4. Participation in another study or program that includes directly observed therapy. 5. Use of ART regimens that are expressly discouraged in DHHS HIV clinical care guidelines Triple-class antiretroviral resistance will be defined according to IAS-USA interpretive guidelines: NRTI class - 3 thymidine or non-thymidine-associated mutations (excluding the M184V mutation) or a multi-nucleoside resistance mutation in reverse transcriptase; PI class - 3 protease mutations, including 1 primary mutation; NNRTI class - 1 primary (K103N or Y188L) or 2 secondary NNRTI-associated mutations in reverse transcriptase. --- M184V --- --- K103N ---


2 M184V

Current plasma HIV RNA > 500 copies/ml 7. Initiating ART for first time, reinitiating therapy after stopping, or changing therapy due to virologic failure 8. ART with at least 3 agents, including a protease inhibitor, a non-nucleoside reverse transcriptase inhibitor, or abacavir 9. Methadone or buprenorphine maintenance therapy > 3 weeks, with no planned detoxification Exclusion Criteria: 1. Need to use ART dosed more frequently than twice daily, 2. Need to use a liquid preparation of antiretroviral medication, 3. Documented triple-class antiretroviral resistance (defined below), 4. Participation in another study or program that includes directly observed therapy. 5. Use of ART regimens that are expressly discouraged in DHHS HIV clinical care guidelines Triple-class antiretroviral resistance will be defined according to IAS-USA interpretive guidelines: NRTI class - 3 thymidine or non-thymidine-associated mutations (excluding the M184V mutation) or a multi-nucleoside resistance mutation in reverse transcriptase; PI class - 3 protease mutations, including 1 primary mutation; NNRTI class - 1 primary (K103N or Y188L) or 2 secondary NNRTI-associated mutations in reverse transcriptase. --- M184V ---


3 Y188L

Current plasma HIV RNA > 500 copies/ml 7. Initiating ART for first time, reinitiating therapy after stopping, or changing therapy due to virologic failure 8. ART with at least 3 agents, including a protease inhibitor, a non-nucleoside reverse transcriptase inhibitor, or abacavir 9. Methadone or buprenorphine maintenance therapy > 3 weeks, with no planned detoxification Exclusion Criteria: 1. Need to use ART dosed more frequently than twice daily, 2. Need to use a liquid preparation of antiretroviral medication, 3. Documented triple-class antiretroviral resistance (defined below), 4. Participation in another study or program that includes directly observed therapy. 5. Use of ART regimens that are expressly discouraged in DHHS HIV clinical care guidelines Triple-class antiretroviral resistance will be defined according to IAS-USA interpretive guidelines: NRTI class - 3 thymidine or non-thymidine-associated mutations (excluding the M184V mutation) or a multi-nucleoside resistance mutation in reverse transcriptase; PI class - 3 protease mutations, including 1 primary mutation; NNRTI class - 1 primary (K103N or Y188L) or 2 secondary NNRTI-associated mutations in reverse transcriptase. --- M184V --- --- K103N --- --- Y188L ---



HPO Nodes