Trial Outcomes & Findings for HIV-Tb Confections Among HIV Patients (NCT NCT02964767)

Results Overview

% Prevalence of HIV/Tb. co infections= no.of HIV/Tb. co infection (48)/total no. of enrolled patients of HIV including HIV/Tb. co infections (219) x 100, i.e. 21.9%

Recruitment status

COMPLETED

Target enrollment

219 participants

Primary outcome timeframe

12 months

Results posted on

2017-10-04

Participant Flow

Patients with HIV infection enrolled at ART centre, Khagaria, India, during June'2015 to May'2016 were recruited.

patients, who were Lost to Follow Up (LFU), were excluded from study.

Participant milestones

Participant milestones
Measure	HIV, HIV mono infected patients,	HIV/Tb. Patients with HIV/Tb. co infection
Overall Study STARTED	171	48
Overall Study COMPLETED	171	48
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

HIV-Tb Confections Among HIV Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1.HIV n=171 Participants patients with mono HIV infections	2.HIV/Tb. n=48 Participants Patients with HIV/Tb. co infections	Total n=219 Participants Total of all reporting groups
Age, Continuous	33.26 years STANDARD_DEVIATION 12.77 • n=5 Participants	34.97 years STANDARD_DEVIATION 11.21 • n=7 Participants	33.63 years STANDARD_DEVIATION 11.20 • n=5 Participants
Sex: Female, Male Female	80 Participants n=5 Participants	14 Participants n=7 Participants	94 Participants n=5 Participants
Sex: Female, Male Male	91 Participants n=5 Participants	34 Participants n=7 Participants	125 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

% Prevalence of HIV/Tb. co infections= no.of HIV/Tb. co infection (48)/total no. of enrolled patients of HIV including HIV/Tb. co infections (219) x 100, i.e. 21.9%

Outcome measures

Outcome measures
Measure	Prevalence of HIV/Tb. co Infection n=219 Participants Percentage of Tb. co infections among HIV patients enrolled at ART center.	2.HIV/Tb. Patients with HIV/Tb. co infections
Prevalence of HIV/Tb. co Infections Among Patients of HIV Enrolled at ART Center.	48 participants	—

SECONDARY outcome

Timeframe: 12 months

CD4 cell counts of HIV patients and HIV/co infection patients would be analysed by student T test, and p value would be estimated.

Outcome measures

Outcome measures
Measure	Prevalence of HIV/Tb. co Infection n=171 Participants Percentage of Tb. co infections among HIV patients enrolled at ART center.	2.HIV/Tb. n=48 Participants Patients with HIV/Tb. co infections
Comparing CD4+ T Cell Count in HIV-Tb. and HIV Cases.	314.63 cells/µL Standard Deviation 317.49	254.29 cells/µL Standard Deviation 218.19

Adverse Events

HIV,

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

HIV/Tb. co Infections

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	HIV, n=171 participants at risk HIV patients	HIV/Tb. co Infections n=48 participants at risk Patients with HIV-Tb. co infections
Nervous system disorders giddiness	3.5% 6/171 • Number of events 8 • 12 months other opportunistic infections	4.2% 2/48 • Number of events 6 • 12 months other opportunistic infections

Additional Information

Dr. Ranjan K Singh

SinghRK

Phone: 91+9431263911

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place