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Report for Clinical Trial NCT01338025

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Evaluation of 3TC or FTC Mono-therapy Compared to Continuing HAART as a Bridging Antiretroviral Strategy in Persistently Non-adherent Children, Adolescents, and Young Adults Who Are Failing HAART and Have the M184V Resistance Mutation.

The purpose of this study was to compare the use of lamivudine (3TC) or emtricitabine (FTC) alone vs. continuing a failing highly active antiretroviral therapy (HAART) regimen in HIV infected children, adolescents and young adults. The study was to see if there were changes in the HIV virus and if there were differences in immune function, viral load and medication side effects between the two groups over 28 weeks. Participants were assigned to either take 3TC or FTC alone or continue on his/her current failing HAART regimen. During the first 28 weeks of this study, if the participant was randomized to the continue HAART arm, he/she was not switched to a different or new, potentially suppressive HAART regimen, but continued on the current failing HAART regimen. However, if continuing HAART, the participant might be switched to a new regimen if their provider felt that it was clinically needed or the participant met certain study endpoints (e.g., drop in CD4, increase in viral load). At the end of 28 weeks, the participant had the choice of remaining on the assigned study group medication(s) or starting a new HAART regimen prescribed by his/her doctor. Then, they would be followed for another 24 weeks to compare the difference in immune function, viral load and medication side effects between the different groups.

NCT01338025 HIV Disease
MeSH: Acquired Immunodeficiency Syndrome HIV Infections

2 Interventions

Name: HAART regimen

Description: The study participant continued their non-suppressive HAART regimen as prescribed by their primary provider.

Type: Drug

Arm A, non-suppressive HAART regimen

Name: 3TC or FTC monotherapy

Description: The study participant was assigned to either 3TC or FTC monotherapy (the choice of 3TC or FTC was left to the provider.

Type: Drug

Arm B, 3TC or FTC monotherapy


Primary Outcomes

Description: Immunologic deterioration was declared for a participant if any one of the following conditions is observed within the first 28 weeks: greater than or equal to 30% decline in absolute CD4+ T cell count from entry, or development of CDC class C events. Results report number of participants with immunologic deterioration at week 28 calculated.

Measure: Number of Participants With Immunologic Deterioration

Time: From entry to week 28

Secondary Outcomes

Description: Change in CD4+ T cell count from entry to Week 28 (CD4+ at entry - CD4+ at Week 28).

Measure: Change in CD4+ T Cell Count

Time: Entry to week 28

Description: Change in HIV-1 RNA levels from Entry to Week 28

Measure: Change in HIV-1 RNA Levels

Time: 28 Weeks

Description: Number of participants reporting a missed medication dose in the past 3 days.

Measure: Number of Participants Non-adherent as Measured by 3-day Recall

Time: 28 Weeks

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 M184V

Evaluation of 3TC or FTC Mono-therapy Compared to Continuing HAART as a Bridging Antiretroviral Strategy in Persistently Non-adherent Children, Adolescents, and Young Adults Who Are Failing HAART and Have the M184V Resistance Mutation.. Evaluation of 3TC or FTC Mono-therapy Compared to Continuing HAART as a Bridging Strategy The purpose of this study was to compare the use of lamivudine (3TC) or emtricitabine (FTC) alone vs. continuing a failing highly active antiretroviral therapy (HAART) regimen in HIV infected children, adolescents and young adults. --- M184V ---

- CD4+ T cell count greater than or equal to 100 cells/mm3 (confirmed on at least two occasions within 6 months of study entry, including the screening value) - Documentation of the M184V mutation on genotypic testing at any time prior to study entry - In the best judgment of the clinical site team, concerns about the subject's ability to adhere made it unsuitable to initiate a new optimal HAART regimen for at least 6 months. --- M184V ---



HPO Nodes