Albuvirtide in Combination With 3BNC117 in Patients With Multi-Drug Resistant (MDR) HIV-1 Infection (NCT04560569) | Clinical Trial Compass
UnknownPhase 2
Albuvirtide in Combination With 3BNC117 in Patients With Multi-Drug Resistant (MDR) HIV-1 Infection
United States20 participantsStarted 2021-11-30
Plain-language summary
The primary objectives are to assess the antiviral activity, clinical safety and tolerability parameters of albuvirtide/3BNC117 combination therapy in reducing HIV-1 viral load during the 1-week induction period treatment period.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Males and females, age ≥ 18 years;
✓. HIV-1 seropositive with documented HIV-1 infection by official, signed, written history (e.g. Laboratory report)
✓. Receiving a combination antiretroviral therapy (cART) (failing regimen) for at least 8 weeks before Screening and are willing to continue on the failing regimen during the Screening Phase and up to Day 14 of the Treatment Phase, OR have failed in the past 8 weeks of Screening, are off therapy and are willing to stay off therapy until Day 14 of the Treatment Phase;
✓. Plasma HIV-1 RNA ≥ 1000 copies/mL at the Screening Visit and documented detectable viral load (HIV-1 RNA \>200 copies/ml) within the last 3 months prior to the Screening Visit;
✓. Highly treatment-experienced HIV-infected patients with genotypic and/or phenotypic resistance to at least one ARV drug for each of three or more drug classes of antiretroviral medications at the Screening Visit and have difficulty in constructing a viable suppressive regimen;
✓. Have full viral sensitivity/susceptibility to at least one approved antiretroviral agent, other than ABT and 3BNC117, as determined by genotypic and/or phenotypic ARV drug resistance tests at screening, and such agent can be used as a component of OBR;
✓. Be willing to remain on treatment without any changes or additions to the OBR regimen, except for toxicity management or upon meeting criteria for treatment failure;
✓. Have a life expectancy that is \> 9 months;
Exclusion criteria
✕. Subject having ≥0.5 log10 reduction in HIV-1 RNA viral load from the Screening Visit to Baseline Visit (Day 0).
What they're measuring
1
Proportion of participants with ≥0.5 log10 reduction in HIV-1 RNA viral load from baseline (Day 7) to Day 14 as compared to the control period from Day 0 to Day 7.