Clareo Health | Efficacy, and Safety Study of Optimized Background Antiretroviral Regimen (OB) in Combination With Enfuvirtide in the Treatment-Experienced Participants With Human Immunodeficiency Virus-1 (HIV-1) Infection
Efficacy, and Safety Study of Optimized Background Antiretroviral Regimen (OB) in Combination With Enfuvirtide in the Treatment-Experienced Participants With Human Immunodeficiency Virus-1 (HIV-1) Infection
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Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Participants with HIV-1 infection
Female participants without any risk of pregnancy
Participants previously treated with drugs of 2 or 3 different antiretroviral classes
Participants currently on highly active antiretroviral treatment (HAART) for more than 4 weeks and with a plasma viral load between 1,000 and 300,000 copies of HIV-1 ribonucleic acid per milliliter (RNA/mL)
Participants with the possibility of potentially effective OB without enfuvirtide, consisting to 2 to 5 drugs, at least two of which are active from at least two different antiretroviral classes
Cluster of differentiation 4 (CD4) cell count greater than (\>) 50 cells/cubic millimeter (mm\^3) at screening
Participants in whom resistance mutations have been detected in reverse transcriptase and/or protease genes
Enfuvirtide-naive participants
You may not be if
Women of childbearing age not using effective mechanical contraception
Pregnant or breastfeeding women
Presence of HIV-2 coinfection
Participants participating or having participated to another clinical trial during the 30 days prior to selection for this trial
Participants having previously been treated with enfuvirtide
Presence active opportunistic infection within 1 month of study entry
Existence of Grade 4 clinical or laboratory abnormalities
Cirrhosis or severe hepatic failure
Uncontrolled diabetes or requiring insulin
Consumption of alcohol and/or narcotics and/or other substances
