Trial Outcomes & Findings for Inducing Immune Quiescence to Prevent HIV Infection in Women (NCT NCT02079077)

NCT ID: NCT02079077

Last Updated: 2019-10-10

Results Overview

We will analyse reduce of immune activation by measuring change in T cell activation (CD69) between baseline and every month during drug administration phase (8 weeks).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 91 participants
• Primary outcome timeframe: Baseline and 8 weeks
• Results posted on: 2019-10-10

Participant Flow

Participant milestones

Measure	Acetylsalicylic Acid (ASA) ASA 81 mg. p.o. daily for two months Acetylsalicylic Acid (ASA): Acetylsalicylic Acid (ASA) 81 mg. oral daily for two months	Hydroxychloroquine (HCQ) Hydroxychloroquine (HCQ) 200 mg. o.d. p.o. for two months. Hydroxychloroquine (HCQ): Hydroxychloroquine (HCQ) 200 mg. oral, daily for two months.
Overall Study STARTED	43	48
Overall Study COMPLETED	37	39
Overall Study NOT COMPLETED	6	9

Reasons for withdrawal

Measure	Acetylsalicylic Acid (ASA) ASA 81 mg. p.o. daily for two months Acetylsalicylic Acid (ASA): Acetylsalicylic Acid (ASA) 81 mg. oral daily for two months	Hydroxychloroquine (HCQ) Hydroxychloroquine (HCQ) 200 mg. o.d. p.o. for two months. Hydroxychloroquine (HCQ): Hydroxychloroquine (HCQ) 200 mg. oral, daily for two months.
Overall Study Lost to Follow-up	5	7
Overall Study Became STIs Positive	1	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Acetylsalicylic Acid (ASA) n=43 Participants ASA 81 mg. p.o. daily for two months Acetylsalicylic Acid (ASA): Acetylsalicylic Acid (ASA) 81 mg. oral daily for two months	Hydroxychloroquine (HCQ) n=48 Participants Hydroxychloroquine (HCQ) 200 mg. o.d. p.o. for two months. Hydroxychloroquine (HCQ): Hydroxychloroquine (HCQ) 200 mg. oral, daily for two months.	Total n=91 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=43 Participants	0 Participants n=48 Participants	0 Participants n=91 Participants
Age, Categorical Between 18 and 65 years	43 Participants n=43 Participants	48 Participants n=48 Participants	91 Participants n=91 Participants
Age, Categorical >=65 years	0 Participants n=43 Participants	0 Participants n=48 Participants	0 Participants n=91 Participants
Sex: Female, Male Female	43 Participants n=43 Participants	48 Participants n=48 Participants	91 Participants n=91 Participants
Sex: Female, Male Male	0 Participants n=43 Participants	0 Participants n=48 Participants	0 Participants n=91 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Kenya	43 participants n=43 Participants	48 participants n=48 Participants	91 participants n=91 Participants
T cell immune activation	30.82 percentage of cells STANDARD_DEVIATION 20.08 • n=43 Participants	30.49 percentage of cells STANDARD_DEVIATION 14.34 • n=48 Participants	30.64 percentage of cells STANDARD_DEVIATION 15.06 • n=91 Participants

PRIMARY outcome

Timeframe: Baseline and 8 weeks

Population: general population

We will analyse reduce of immune activation by measuring change in T cell activation (CD69) between baseline and every month during drug administration phase (8 weeks).

Outcome measures

Measure	Acetylsalicylic Acid (ASA) n=43 Participants ASA 81 mg. p.o. daily for two months Acetylsalicylic Acid (ASA): Acetylsalicylic Acid (ASA) 81 mg. oral daily for two months	Hydroxychloroquine (HCQ) n=48 Participants Hydroxychloroquine (HCQ) 200 mg. o.d. p.o. for two months. Hydroxychloroquine (HCQ): Hydroxychloroquine (HCQ) 200 mg. oral, daily for two months.
Changes in Systemic Immune Activation From Baseline Observed by the CD69 Expression on CD4 T Cells Average of CD4+CD69+ at baseline	4.04 percentage of cells Standard Deviation 3.83	5.55 percentage of cells Standard Deviation 5.09
Changes in Systemic Immune Activation From Baseline Observed by the CD69 Expression on CD4 T Cells Average of CD4+CD69+ T cells cells after treatment	4.9 percentage of cells Standard Deviation 4.4	4.99 percentage of cells Standard Deviation 3.56

SECONDARY outcome

Timeframe: baseline and 8 weeks

We will measure changes in the number of CD4+T cells expressing CCR5 at the female genital tract before and at the end of the study.

Outcome measures

Measure	Acetylsalicylic Acid (ASA) n=43 Participants ASA 81 mg. p.o. daily for two months Acetylsalicylic Acid (ASA): Acetylsalicylic Acid (ASA) 81 mg. oral daily for two months	Hydroxychloroquine (HCQ) n=48 Participants Hydroxychloroquine (HCQ) 200 mg. o.d. p.o. for two months. Hydroxychloroquine (HCQ): Hydroxychloroquine (HCQ) 200 mg. oral, daily for two months.
Change in Number of CCR5+CD4+ T Cell Population at the Female Genital Tract.	17.60 percentage of cells Standard Deviation 11.27	22.10 percentage of cells Standard Deviation 14.93

Adverse Events

Acetylsalicylic Acid (ASA)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Hydroxychloroquine (HCQ)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Keith Fowke

University of Manitoba

Phone: 204-789-3296

Email: keith.fowke@umanitoba.ca

Results disclosure agreements

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