Trial Outcomes & Findings for Improving Prognosis in HIV Infection (NCT NCT02640625)

NCT ID: NCT02640625

Last Updated: 2021-12-06

Results Overview

Number of Participants who Experienced Adverse Effects

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 20 participants
• Primary outcome timeframe: 10 weeks
• Results posted on: 2021-12-06

Participant Flow

Participant milestones

Measure	Probiotic Compound Lactobacillus rhamnosus GG, Lactobacillus acidophilus, Lactobacillus bulgaricus, Bifidobacterium animalis subsp. lactis, and Streptococcus thermophilus. Probiotic compound: Lactobacillus rhamnosus GG, Lactobacillus acidophilus, Lactobacillus bulgaricus, Bifidobacterium animalis subsp. lactis, and Streptococcus thermophilus.
Overall Study STARTED	20
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Probiotic Compound Lactobacillus rhamnosus GG, Lactobacillus acidophilus, Lactobacillus bulgaricus, Bifidobacterium animalis subsp. lactis, and Streptococcus thermophilus. Probiotic compound: Lactobacillus rhamnosus GG, Lactobacillus acidophilus, Lactobacillus bulgaricus, Bifidobacterium animalis subsp. lactis, and Streptococcus thermophilus.
Overall Study Adverse Event	1

Baseline Characteristics

Improving Prognosis in HIV Infection

Baseline characteristics by cohort

Measure	Probiotic Intervention n=20 Participants HIV positive on cART \>4 years with CD4 \<400 cells/ml and HIV RNA \<50 copies/ml
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	49 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	20 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Norway	20 participants n=5 Participants
HBsAg negative AND HCV RNA negative AND no gastrointestinal disorders	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: 10 weeks

Number of Participants who Experienced Adverse Effects

Outcome measures

Measure	Probiotic Intervention n=20 Participants HIV positive on cART \>4 years with CD4 \<400 cells/ml and HIV RNA \<50 copies/ml
Adverse Effects	1 Participants

PRIMARY outcome

Timeframe: 8 weeks

Unit og Measure: copies/mL

Outcome measures

Measure	Probiotic Intervention n=19 Participants HIV positive on cART \>4 years with CD4 \<400 cells/ml and HIV RNA \<50 copies/ml
Delta HIV Viral Load	0 copies/mL Interval -2.0 to 31.0

PRIMARY outcome

Timeframe: 8 weeks

Unit of Measure: cells/microL

Outcome measures

Measure	Probiotic Intervention n=19 Participants HIV positive on cART \>4 years with CD4 \<400 cells/ml and HIV RNA \<50 copies/ml
Delta Blood CD4 Count	18 cells/microL Interval -372.0 to 145.0

SECONDARY outcome

Timeframe: 8 weeks

Explorative (Unit of Measure: Descriptive)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

Explorative (Unit of Measure: Descriptive)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

Explorative assays on T cell subsets distribution and function (Unit of Measure: Frequency)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

Explorative assays on T cell receptor signaling mechanism (Unit of Measure: Frequency)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

Explorative assays on soluble inflammation markers and lymphoid cells activation status (Unit of Measure: Descriptive)

Outcome measures

Outcome data not reported

Adverse Events

Probiotic Intervention

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Probiotic Intervention n=20 participants at risk HIV positive on cART \>4 years with CD4 \<400 cells/ml and HIV RNA \<50 copies/ml
Gastrointestinal disorders Acute cholecystitis with E. coli bacteremia	5.0% 1/20 • Number of events 1 • 14 months

Additional Information

Dr. Dag Henrik Reikvam

Oslo University Hospital

Phone: +4722119881

Email: dagrei@ous-hf.no

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place