Trial Outcomes & Findings for Helping HIV Infected Patients in South Africa Adhere to Drug Regimens (NCT NCT00076804)

NCT ID: NCT00076804

Last Updated: 2015-03-27

Results Overview

Proportion of Patients with HIV RNA Levels of \<400 at 12 Months - Intention-to-treat

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 274 participants
• Primary outcome timeframe: at 12 and 24 months of treatment
• Results posted on: 2015-03-27

Participant Flow

The study site was a public sector ART clinic at the GF Jooste Hospital, a secondary level facility in Cape Town, Western Cape province of South Africa, serving several peri-urban townships. Enrollment began February 13, 2005, and ended on July 7, 2007, with the last follow-up occurring on July 25, 2008.

Participant milestones

Measure	Peer Supporter Use of a patient nominated peer supporter who sill observe the morning dose of ARVs	Self Administration Self administration of ARVs
Overall Study STARTED	137	137
Overall Study COMPLETED	77	68
Overall Study NOT COMPLETED	60	69

Reasons for withdrawal

Measure	Peer Supporter Use of a patient nominated peer supporter who sill observe the morning dose of ARVs	Self Administration Self administration of ARVs
Overall Study Death	9	20
Overall Study Lost to Follow-up	9	9
Overall Study Withdrawal by Subject	10	8
Overall Study Early study Closure	32	32

Baseline Characteristics

Helping HIV Infected Patients in South Africa Adhere to Drug Regimens

Baseline characteristics by cohort

Measure	Peer Supporter n=137 Participants Use of a patient nominated peer supporter who sill observe the morning dose of ARVs	Self Administration n=137 Participants Self administration of ARVs	Total n=274 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	134 Participants n=5 Participants	136 Participants n=7 Participants	270 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Age, Continuous	35.7 years STANDARD_DEVIATION 9.7 • n=5 Participants	36.7 years STANDARD_DEVIATION 9.2 • n=7 Participants	36.2 years STANDARD_DEVIATION 9.1 • n=5 Participants
Sex: Female, Male Female	79 Participants n=5 Participants	79 Participants n=7 Participants	158 Participants n=5 Participants
Sex: Female, Male Male	58 Participants n=5 Participants	58 Participants n=7 Participants	116 Participants n=5 Participants
Region of Enrollment South Africa	137 participants n=5 Participants	137 participants n=7 Participants	274 participants n=5 Participants

PRIMARY outcome

Timeframe: at 12 and 24 months of treatment

Proportion of Patients with HIV RNA Levels of <400 at 12 Months - Intention-to-treat

Outcome measures

Measure	Peer Supporter n=136 Participants Use of a patient nominated peer supporter who sill observe the morning dose of ARVs	Self Administration n=136 Participants Self administration of ARVs
Impact of DOT Compared to Self-administered Treatment as Measured by HIV Viral Load at 12 Months of Treatment	99 participants	93 participants

PRIMARY outcome

Timeframe: 24 months

Proportion of Patients with HIV RNA Levels of <400 Copies/mL at 24 Months [Intention-to-treat (ITT)

Outcome measures

Measure	Peer Supporter n=104 Participants Use of a patient nominated peer supporter who sill observe the morning dose of ARVs	Self Administration n=104 Participants Self administration of ARVs
Impact of DOT Compared to Self-administered Treatment as Measured by HIV Viral Load at 24 Months of Treatment	63 participants	62 participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Measure	Peer Supporter n=105 Participants Use of a patient nominated peer supporter who sill observe the morning dose of ARVs	Self Administration n=100 Participants Self administration of ARVs
Immunological Response: Median CD4 (IQR) Cell Count Increase From Baseline at 12 Months by Study Arm	185 cells/uL Interval 108.0 to 276.0	160 cells/uL Interval 78.0 to 236.0

PRIMARY outcome

Timeframe: 24 months

Outcome measures

Measure	Peer Supporter n=84 Participants Use of a patient nominated peer supporter who sill observe the morning dose of ARVs	Self Administration n=77 Participants Self administration of ARVs
Immunological Response: Median CD4 (IQR) Cell Count Increase From Baseline at 24 Months by Study Arm	281 cells/uL Interval 144.0 to 403.0	262 cells/uL Interval 149.0 to 363.0

Adverse Events

Peer Supporter

Serious events: 19 serious events

Other events: 71 other events

Deaths: 0 deaths

Self Administration

Serious events: 29 serious events

Other events: 89 other events

Deaths: 0 deaths

Serious adverse events

Measure	Peer Supporter n=137 participants at risk Use of a patient nominated peer supporter who sill observe the morning dose of ARVs	Self Administration n=137 participants at risk Self administration of ARVs
General disorders Death	6.6% 9/137 • Number of events 9 • Adverse Event data was collected throughout the duration of the study. It was assessed at each clinic visit and if the subject presented between visits.	14.6% 20/137 • Number of events 20 • Adverse Event data was collected throughout the duration of the study. It was assessed at each clinic visit and if the subject presented between visits.
General disorders DAIDS Grade IV AE	3.6% 5/137 • Number of events 5 • Adverse Event data was collected throughout the duration of the study. It was assessed at each clinic visit and if the subject presented between visits.	1.5% 2/137 • Number of events 2 • Adverse Event data was collected throughout the duration of the study. It was assessed at each clinic visit and if the subject presented between visits.
General disorders Hospitalization	3.6% 5/137 • Number of events 5 • Adverse Event data was collected throughout the duration of the study. It was assessed at each clinic visit and if the subject presented between visits.	5.1% 7/137 • Number of events 7 • Adverse Event data was collected throughout the duration of the study. It was assessed at each clinic visit and if the subject presented between visits.

Other adverse events

Measure	Peer Supporter n=137 participants at risk Use of a patient nominated peer supporter who sill observe the morning dose of ARVs	Self Administration n=137 participants at risk Self administration of ARVs
General disorders AIDS-Defining Illness	16.1% 22/137 • Number of events 28 • Adverse Event data was collected throughout the duration of the study. It was assessed at each clinic visit and if the subject presented between visits.	22.6% 31/137 • Number of events 35 • Adverse Event data was collected throughout the duration of the study. It was assessed at each clinic visit and if the subject presented between visits.
General disorders DAIDS Grade III Event	12.4% 17/137 • Number of events 22 • Adverse Event data was collected throughout the duration of the study. It was assessed at each clinic visit and if the subject presented between visits.	15.3% 21/137 • Number of events 25 • Adverse Event data was collected throughout the duration of the study. It was assessed at each clinic visit and if the subject presented between visits.
General disorders New Diagnosis/Worsening Medical Condition	23.4% 32/137 • Number of events 39 • Adverse Event data was collected throughout the duration of the study. It was assessed at each clinic visit and if the subject presented between visits.	27.0% 37/137 • Number of events 52 • Adverse Event data was collected throughout the duration of the study. It was assessed at each clinic visit and if the subject presented between visits.

Additional Information

Richard E. Chaisson

Johns Hopkins University Center for TB Research

Phone: 4109551755

Email: rchaiss@jhmi.edu

Results disclosure agreements

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