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HPTN 052- A Randomized Trial to Evaluate the Effectiveness of Antiretroviral Therapy Plus HIV Primary Care versus HIV Primary Care Alone to Prevent the Sexual Transmission of HIV-1 in Serodiscordant Couples


Summary

HPTN 052 is a Phase III, two-arm, multi-site, randomized trial to determine the effectiveness of two treatment strategies in preventing the sexual transmission of HIV in HIV-serodiscordant couples.

Based on data collected in Africa and Thailand, there is a correlation between HIV viral load (blood levels) and HIV transmission. Specifically, the higher the viral load in the blood, the more likely the chance for transmission. Antiretroviral therapy (ART) reduces the viral load in the blood, as well as in genital secretions (for both men and women), and the drugs can be detected in semen and vaginal and cervical secretions. All of this information strongly suggests that ART may make HIV-infected people less contagious. HPTN 052 compares the HIV-infection rates of two groups of HIV-serodiscordant couples. The index case of the first group starts taking ART as soon as the couple is enrolled in the study, while the index case of the second group starts taking ART when his or her CD4+ cell count drops to 200 cells/mm3 or when he or she develops an AIDS-defining illness. Both groups will receive HIV primary care and couples counseling sessions to teach them how to reduce their risk of transmission.

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