HIV is transmitted primarily through vaginal and anal intercourse, and a high concentration of HIV in semen and cervico-vaginal fluid is one factor likely to increase sexual transmission from infected individuals to their sex partners. As the genital fluids and blood are separate immunologic compartments, if HIV replication is not suppressed sufficiently it may evolve differently in the genital and blood compartments and this may result in a different spectrum of drug resistance associated mutations. This substudy of the EARNEST trial therefore aims to determine the level to which the three different boosted protease inhibitor (bPI) containing second-line treatment regimens used in EARNEST are suppressing viral replication in genital secretions and to compare the magnitude of viral replication in genital secretions with the magnitude of viral replication in the plasma of these patients. For those patients with a detectable viral load the drug resistance profile in genital secretions will be compared to the drug resistance profile in plasma.
The study aims has enroleld 124 men and women at seven different sites in Uganda, namely the JCRC sites in Fort Portal, Kabale, Kakira, Kampala, Mbale and Mbarara and at Nsambya Hospital in Kampala. Analysis of the substudy samples is currently ongoing.