Clinical trials using HIV-1 RNA-based primary endpoints: statistical analysis and potential biases

Article Abstract:

Clinical trials with endpoints designed to determine the amount of reduction of HIV-1 RNA levels in the body provide an important body of information distinct from that usually sought, which is the number of people who have a complete reduction of viral count. That crude analysis limited to total reduction of the viral load can easily mask the value and efficacy of another form(s) of treatment which may significantly lower viral load to the benefit of the well-being of the patient, but which would not be accounted for due to the limited parameters of the test.

Prognosis

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Anti retroviral Therapy for HIV Infection in 1998, Part 6

Article Abstract:

The International AIDS Society-USA recommends early antiviral therapy, guided by viral load monitoring, for people infected with HIV. Patients effectively treated with a combination of protease inhibitor and reverse transcriptase inhibitor antiretroviral medications for over 2 years do not develop drug-resistant viral mutations. Early drug treatment substantially reduces hospitalizations and illness among HIV patients. Viral load monitoring can indicate the effectiveness of drug treatment regimens and guide changes in therapy.

Health aspects, Reports, Drug therapy, Antiviral agents, International AIDS Society

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Virologic and Regimen Termination Surrogate End Points in AIDS Clinical Trials

Article Abstract:

Many trials of AIDS drugs use a suppression of viral reproduction as proof of the treatment's effectiveness. However, the regimen termination surrogate endpoint may be more accurate because it includes a change in treatment due to drug resistance in the virus or toxic side effects of the drug. Either or both endpoints can be used depending on the nature of the research trial.

Research, Methods, Clinical trials, AIDS (Disease), AIDS research

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