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Report for Clinical Trial NCT00121979

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Exploring the Safety, Tolerability, and Antiviral Effect of Substituting 600 mg Racivir for 3TC in HIV-Infected Subjects Who Have the M184V Mutation and Are Currently Failing on a HAART Regimen Containing Lamivudine

Racivir ® (RCV) is an experimental drug which means it is not approved for use by the United States Food and Drug Administration (FDA), but it can be used in research studies like this one. RCV (Racivir®) is part of a class of drugs known as "Nucleoside Reverse Transcriptase Inhibitors" (NRTIs), which are intended to block a further increase in the amount of HIV virus in the body. Laboratory research suggests that RCV (Racivir®) may be effective in patients who have developed resistance to other NRTIs, particularly 3TC (lamivudine, Epivir®). However, a study of RCV (Racivir®) has not been done with patients who have previously been treated with other HAART (Highly Active Antiretroviral Therapy -- taking multiple HIV drugs at once) medications including 3TC (lamivudine, Epivir®). The purpose of this study is to evaluate the safety and effectiveness of RCV (Racivir®) when used together with other HIV drugs in people who have previously been treated with 3TC (lamivudine, Epivir®) and are failing with their current HAART treatments. This study will include a total of 60 HIV infected, HAART-experienced subjects currently receiving 3TC (lamivudine, Epivir®) as part of their HAART therapy. The study will take place at approximately 11 study sites in the US and Latin America.

NCT00121979 HIV Infections
MeSH: HIV Infections

1 Interventions

Name: Racivir, a non-nucleoside reverse transcriptase inhibitor

Type: Drug


Primary Outcomes

Measure: Change from baseline in virological response of HIV (log10 HIV-RNA levels) at the end of week 2

Measure: Change from baseline in CD4+ count at the end of week 2

Measure: Adverse events

Secondary Outcomes

Measure: Proportion of subjects in each treatment arm with viral load reduction ≥ 0.5 log10 from baseline

Measure: Proportion of subjects in each treatment arm with viral load below 50 copies/mL

Purpose: Treatment

Allocation: Randomized

Factorial Assignment


There are 3 SNPs

SNPs


1 M184V

Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Exploring the Safety, Tolerability, and Antiviral Effect of Substituting 600 mg Racivir for 3TC in HIV-Infected Subjects Who Have the M184V Mutation and Are Currently Failing on a HAART Regimen Containing Lamivudine. --- M184V ---

- Subjects who have the M184V HIV mutation, as determined by the FDA-approved Bayer assay, TRUGENE® HIV-1 Genotyping Kit and the OpenGene® DNA Sequencing System. --- M184V ---


2 Q151M

- Subjects with Q151M mutation. --- Q151M ---


3 T69S

- Subjects with T69S insertions. --- T69S ---



HPO Nodes