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

NCT03431168 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: IRB-300001112
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 1

Brief Summary

More than 3 billion people worldwide are at risk of acquiring malaria and pregnant women living with HIV in Africa are at particular risk. An effective prophylaxis regimen capable of preventing malaria and other common perinatal infections would have great potential to improve adverse birth outcomes. The purpose of this randomized controlled trial is to evaluate a new combination prophylaxis regimen in pregnant women with HIV in Cameroon to determine its efficacy and safety.

Conditions

HIV; Pregnancy Malaria; Sexually Transmitted Infection

Keywords

STI Prevention; Cameroon; sub-Saharan Africa; HIV pregnancy; Malaria in pregnancy

Outcome Measures

Primary Outcomes (2)

• Plasmodium Falciparum Peripheral Parasitemia

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

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

• Proportion With Composite STI Outcome

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

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

Secondary Outcomes (8)

• Low Birthweight (<2500 Grams)

  at birth

• Proportion With Adverse Birth Outcomes

  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.

• Maternal Adherence to the Prophylactic Regimen

  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.

• Proportion of Participants With Symptomatic Malaria

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

• Proportion With Placental Malaria

  At delivery

Study Arms (2)

Azithromycin/TMPS

ACTIVE COMPARATOR

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.

Drug: Azithromycin/TMPS

Placebo/TMPS

PLACEBO COMPARATOR

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.

Drug: Placebo/TMPS

Interventions

Azithromycin/TMPS DRUG

2 tabs po daily x 3 days at enrollment and at each monthly follow up visit

Also known as: Cotrimoxazole

Azithromycin/TMPS

Placebo/TMPS DRUG

2 tabs po daily x 3 days at enrollment and at each monthly follow up visit

Also known as: Co-Trimoxazole

Placebo/TMPS

Eligibility Criteria

• Age: 16 Years - 55 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Confirmed HIV-infection (documented in medical record)
• Age ≥16 years
• Confirmed pregnancy, \<28 weeks estimated gestational age (by best obstetric estimate which may include ultrasound or fundal height and LMP)
• Live singleton pregnancy
• Receiving prenatal care at Mboppi Hospital or Mutengene Hospital
• Plan to receive follow up prenatal care and deliver at study facility
• Capable of providing written informed consent
• Able and agree to come to facility for febrile episodes or acute illness during pregnancy (with reimbursement of transportation costs).
• Agree to avoid antimalarial medications outside of study protocol.

You may not qualify if:

• Severe anemia (last hemoglobin \<6)
• History of severe adverse reaction to co-trimoxazole or azithromycin
• Active medical problem requiring inpatient evaluation at the time of screening
• Intention of moving far away from the facility during pregnancy or not likely to return for follow up care or delivery
• Signs or symptoms of early or active labor
• History of severe cardiac disease (including congestive heart failure, severe valvular disease or arrhythmias).

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

• Pons-Duran C, Wassenaar MJ, Yovo KE, Marin-Carballo C, Briand V, Gonzalez R. Intermittent preventive treatment regimens for malaria in HIV-positive pregnant women. Cochrane Database Syst Rev. 2024 Sep 26;9(9):CD006689. doi: 10.1002/14651858.CD006689.pub3.

  PMID: 39324693 DERIVED

MeSH Terms

Conditions

Sexually Transmitted Diseases

Interventions

Trimethoprim, Sulfamethoxazole Drug Combination

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Trimethoprim; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Jodie Dionne
• Organization: UAB

jdionne@uabmc.edu

2059756530

Study Officials

• Jodie A Dionne-Odom, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 2, 2018
• First Posted: February 13, 2018
• Study Start: March 7, 2018
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2022
• Last Updated: November 27, 2023
• Results First Posted: May 4, 2022

Record last verified: 2023-11

Locations

US (1)