Trial Outcomes & Findings for A Novel Regimen to Prevent Malaria and STI in Pregnant Women With HIV (NCT NCT03431168)

NCT ID: NCT03431168

Last Updated: 2023-11-27

Results Overview

P. falciparum detected by microscopy or polymerase chain reaction (PCR)

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 308 participants
• Primary outcome timeframe: At end of pregnancy (>35 weeks) or at delivery
• Results posted on: 2023-11-27

Participant Flow

Participant milestones

Measure	Azithromycin/TMPS Azithromycin 1 gm po daily x 3 days at enrollment and at each 4 week follow up visit. TMPS double strength 1 tablet po daily. Azithromycin/TMPS: 2 tabs po daily x 3 days at enrollment and at each monthly follow up visit	Placebo/TMPS Azithromycin placebo 1 gm po daily x 3 days at enrollment and at each 4 week follow up visit. TMPS double strength 1 tablet po daily. Placebo/TMPS: 2 tabs po daily x 3 days at enrollment and at each monthly follow up visit
Overall Study STARTED	155	153
Overall Study COMPLETED	132	129
Overall Study NOT COMPLETED	23	24

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Novel Regimen to Prevent Malaria and STI in Pregnant Women With HIV

Baseline characteristics by cohort

Measure	Azithromycin/TMPS n=155 Participants Azithromycin 1 gm po daily x 3 days at enrollment and at each 4 week follow up visit. TMPS double strength 1 tablet po daily. Azithromycin/TMPS: 2 tabs po daily x 3 days at enrollment and at each monthly follow up visit	Placebo/TMPS n=153 Participants Azithromycin placebo 1 gm po daily x 3 days at enrollment and at each 4 week follow up visit. TMPS double strength 1 tablet po daily. Placebo/TMPS: 2 tabs po daily x 3 days at enrollment and at each monthly follow up visit	Total n=308 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	155 Participants n=5 Participants	153 Participants n=7 Participants	308 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	32 years n=5 Participants	32 years n=7 Participants	32 years n=5 Participants
Sex: Female, Male Female	155 Participants n=5 Participants	153 Participants n=7 Participants	308 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	155 Participants n=5 Participants	153 Participants n=7 Participants	308 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Cameroon	155 participants n=5 Participants	153 participants n=7 Participants	308 participants n=5 Participants

PRIMARY outcome

Timeframe: At end of pregnancy (>35 weeks) or at delivery

P. falciparum detected by microscopy or polymerase chain reaction (PCR)

Outcome measures

Measure	Azithromycin/TMPS n=140 Participants Azithromycin 1 gm po daily x 3 days at enrollment and at each 4 week follow up visit. TMPS double strength 1 tablet po daily. Azithromycin/TMPS: 2 tabs po daily x 3 days at enrollment and at each monthly follow up visit	Placebo/TMPS n=136 Participants Azithromycin placebo 1 gm po daily x 3 days at enrollment and at each 4 week follow up visit. TMPS double strength 1 tablet po daily. Placebo/TMPS: 2 tabs po daily x 3 days at enrollment and at each monthly follow up visit
Plasmodium Falciparum Peripheral Parasitemia	8 Participants	7 Participants

PRIMARY outcome

Timeframe: will be measured in both groups (>35 weeks) or at delivery

Including chlamydia (NAAT (nucleic acid amplification test) positive) , gonorrhea (NAAT positive), syphilis (non-treponemal and treponemal test positive) infections.

Outcome measures

Measure	Azithromycin/TMPS n=140 Participants Azithromycin 1 gm po daily x 3 days at enrollment and at each 4 week follow up visit. TMPS double strength 1 tablet po daily. Azithromycin/TMPS: 2 tabs po daily x 3 days at enrollment and at each monthly follow up visit	Placebo/TMPS n=133 Participants Azithromycin placebo 1 gm po daily x 3 days at enrollment and at each 4 week follow up visit. TMPS double strength 1 tablet po daily. Placebo/TMPS: 2 tabs po daily x 3 days at enrollment and at each monthly follow up visit
Proportion With Composite STI Outcome	2 Participants	2 Participants

SECONDARY outcome

Timeframe: at birth

Neonatal weight measured with digital scale

Outcome measures

Measure	Azithromycin/TMPS n=141 Participants Azithromycin 1 gm po daily x 3 days at enrollment and at each 4 week follow up visit. TMPS double strength 1 tablet po daily. Azithromycin/TMPS: 2 tabs po daily x 3 days at enrollment and at each monthly follow up visit	Placebo/TMPS n=137 Participants Azithromycin placebo 1 gm po daily x 3 days at enrollment and at each 4 week follow up visit. TMPS double strength 1 tablet po daily. Placebo/TMPS: 2 tabs po daily x 3 days at enrollment and at each monthly follow up visit
Low Birthweight (<2500 Grams)	4 Participants	7 Participants

SECONDARY outcome

Timeframe: Birth outcomes will be measured at birth for all outcomes except early neonatal mortality defined as within 7 days of birth. Early neonatal mortality will be assessed at a six week follow up phone call.

Composite measure: low infant birthweight (<2500 grams), miscarriage (<28 weeks), preterm delivery (<37 weeks), small for gestational age (SGA), congenital anomaly detected on surface examination, early neonatal mortality (within 7 days of birth)

Outcome measures

Measure	Azithromycin/TMPS n=155 Participants Azithromycin 1 gm po daily x 3 days at enrollment and at each 4 week follow up visit. TMPS double strength 1 tablet po daily. Azithromycin/TMPS: 2 tabs po daily x 3 days at enrollment and at each monthly follow up visit	Placebo/TMPS n=153 Participants Azithromycin placebo 1 gm po daily x 3 days at enrollment and at each 4 week follow up visit. TMPS double strength 1 tablet po daily. Placebo/TMPS: 2 tabs po daily x 3 days at enrollment and at each monthly follow up visit
Proportion With Adverse Birth Outcomes	13 Participants	20 Participants

SECONDARY outcome

Timeframe: Adherence of study medication taken at home will be documented from the date of randomization until the time of delivery, assessed up to 42 weeks.

Directly observed therapy (DOT) in clinic for the 1st dose of study medication. Self-report and pill count will be used to assess adherence and maternal tolerability for study medications taken at home from the time of enrollment until delivery. At each follow up visit and at delivery, participants will complete a medication adherence survey. They will self-report adherence to the 3 day study regimen (AZ or placebo).

Outcome measures

Measure	Azithromycin/TMPS n=148 Participants Azithromycin 1 gm po daily x 3 days at enrollment and at each 4 week follow up visit. TMPS double strength 1 tablet po daily. Azithromycin/TMPS: 2 tabs po daily x 3 days at enrollment and at each monthly follow up visit	Placebo/TMPS n=148 Participants Azithromycin placebo 1 gm po daily x 3 days at enrollment and at each 4 week follow up visit. TMPS double strength 1 tablet po daily. Placebo/TMPS: 2 tabs po daily x 3 days at enrollment and at each monthly follow up visit
Maternal Adherence to the Prophylactic Regimen	148 Participants	148 Participants

SECONDARY outcome

Timeframe: From the date of randomization until the time of delivery, assessed up to 42 weeks.

Fever and positive malaria test (rapid diagnostic test) at routine visits or sick call visits or maternal report of malaria diagnosis.

Outcome measures

Measure	Azithromycin/TMPS n=148 Participants Azithromycin 1 gm po daily x 3 days at enrollment and at each 4 week follow up visit. TMPS double strength 1 tablet po daily. Azithromycin/TMPS: 2 tabs po daily x 3 days at enrollment and at each monthly follow up visit	Placebo/TMPS n=148 Participants Azithromycin placebo 1 gm po daily x 3 days at enrollment and at each 4 week follow up visit. TMPS double strength 1 tablet po daily. Placebo/TMPS: 2 tabs po daily x 3 days at enrollment and at each monthly follow up visit
Proportion of Participants With Symptomatic Malaria	13 Participants	13 Participants

SECONDARY outcome

Timeframe: At delivery

Placentas will be collected on a subset of women and impression smear will be used to assess for malaria infection

Outcome measures

Measure	Azithromycin/TMPS n=35 Participants Azithromycin 1 gm po daily x 3 days at enrollment and at each 4 week follow up visit. TMPS double strength 1 tablet po daily. Azithromycin/TMPS: 2 tabs po daily x 3 days at enrollment and at each monthly follow up visit	Placebo/TMPS n=35 Participants Azithromycin placebo 1 gm po daily x 3 days at enrollment and at each 4 week follow up visit. TMPS double strength 1 tablet po daily. Placebo/TMPS: 2 tabs po daily x 3 days at enrollment and at each monthly follow up visit
Proportion With Placental Malaria	7 Participants	5 Participants

SECONDARY outcome

Timeframe: At the end of pregnancy (>35 weeks) or at delivery

anemia defined as hemoglobin <11 g/dL, severe anemia defined as hemoglobin <7 g/dL.

Outcome measures

Measure	Azithromycin/TMPS n=148 Participants Azithromycin 1 gm po daily x 3 days at enrollment and at each 4 week follow up visit. TMPS double strength 1 tablet po daily. Azithromycin/TMPS: 2 tabs po daily x 3 days at enrollment and at each monthly follow up visit	Placebo/TMPS n=148 Participants Azithromycin placebo 1 gm po daily x 3 days at enrollment and at each 4 week follow up visit. TMPS double strength 1 tablet po daily. Placebo/TMPS: 2 tabs po daily x 3 days at enrollment and at each monthly follow up visit
Proportion With Maternal Anemia and Severe Maternal Anemia	2 Participants	2 Participants

SECONDARY outcome

Timeframe: After 35 weeks GA or at delivery

Proportion of women with GC/CT (by NAAT), syphilis (by serology), Mycoplasma genitalium (NAAT).

Outcome measures

Measure	Azithromycin/TMPS n=155 Participants Azithromycin 1 gm po daily x 3 days at enrollment and at each 4 week follow up visit. TMPS double strength 1 tablet po daily. Azithromycin/TMPS: 2 tabs po daily x 3 days at enrollment and at each monthly follow up visit	Placebo/TMPS n=153 Participants Azithromycin placebo 1 gm po daily x 3 days at enrollment and at each 4 week follow up visit. TMPS double strength 1 tablet po daily. Placebo/TMPS: 2 tabs po daily x 3 days at enrollment and at each monthly follow up visit
Composite STI Measure (Including All STI Tests)	5 Participants	5 Participants

SECONDARY outcome

Timeframe: at or near term or at delivery

anogenital GBS colonization detected by NAAT (PCR)

Outcome measures

Measure	Azithromycin/TMPS n=147 Participants Azithromycin 1 gm po daily x 3 days at enrollment and at each 4 week follow up visit. TMPS double strength 1 tablet po daily. Azithromycin/TMPS: 2 tabs po daily x 3 days at enrollment and at each monthly follow up visit	Placebo/TMPS n=144 Participants Azithromycin placebo 1 gm po daily x 3 days at enrollment and at each 4 week follow up visit. TMPS double strength 1 tablet po daily. Placebo/TMPS: 2 tabs po daily x 3 days at enrollment and at each monthly follow up visit
GBS Colonization	8 Participants	7 Participants

Adverse Events

Azithromycin/TMPS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo/TMPS

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

Dr. Jodie Dionne

UAB

Phone: 2059756530

Email: jdionne@uabmc.edu

Results disclosure agreements

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