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Antiretroviral
Cabotegravir Injections for PrEP in Breastfeeding Individuals (Tshireletso Trial)
Phase 4
Recruiting
Led By Rebecca Zash, MD
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Tshireletso Trial Summary
This trial will evaluate whether using long-acting cabotegravir injections to prevent HIV in post-partum people is feasible and safe, and whether it works to prevent HIV.
Who is the study for?
This trial is for mothers over 18, within 14 days post-delivery, HIV-negative, with fewer than three prior pregnancies. They must plan to stay in Gaborone or Molepolole regions of Botswana for two years and be willing to receive injections every eight weeks. Exclusions include TB treatment, unstable conditions affecting adherence, care outside government clinics, weight under 35kg, certain medications use or previous reactions to CAB.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of Cabotegravir-LA injections as HIV prevention in breastfeeding post-partum individuals. Participants will get their first dose at the maternity ward followed by doses at local clinics during routine visits. The study monitors on-time injection attendance and reasons for continuation or discontinuation over a period of 24 months.See study design
What are the potential side effects?
Potential side effects may include reactions where the shot was given and possible transfer through breastmilk which could affect infant health. Blood levels in both mother and child will be monitored to assess any health impacts.
Tshireletso Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adherence to CAB-LA injections
Composite Infant Adverse Effects
Composite Maternal Adverse Effects
+3 moreSecondary outcome measures
INSTI resistance among incident HIV infections
Inadequate infant growth
Infant Cabotegravir Levels
+8 moreSide effects data
From 2023 Phase 2 trial • 309 Patients • NCT0212035292%
Injection site pain
24%
Injection site swelling
23%
Nasopharyngitis
21%
Headache
19%
Injection site induration
19%
Diarrhoea
18%
Injection site nodule
17%
Injection site pruritus
16%
Upper respiratory tract infection
15%
Injection site warmth
13%
Injection site bruising
12%
Nausea
11%
Pyrexia
10%
Fatigue
10%
Back pain
9%
Syphilis
8%
Injection site erythema
8%
Pharyngitis
8%
Abdominal pain
8%
Insomnia
7%
Bronchitis
7%
Cough
6%
Gastroenteritis
6%
Gonorrhoea
6%
Anxiety
6%
Anogenital warts
5%
Asthenia
5%
Pharyngotonsillitis
5%
Influenza
5%
Folliculitis
5%
Depression
5%
Rash
5%
Genital herpes
5%
Dizziness
5%
Myalgia
4%
Skin papilloma
4%
Eczema
4%
Haemorrhoids
3%
Sinusitis
3%
Ear infection
3%
Abdominal distension
3%
Cellulitis
3%
Musculoskeletal stiffness
3%
Urethritis
3%
Dyspepsia
3%
Proctalgia
3%
Influenza like illness
3%
Chlamydial infection
3%
Vomiting
3%
Tonsillitis
3%
Conjunctivitis
3%
Respiratory tract infection
3%
Subcutaneous abscess
3%
Rhinitis
3%
Gingivitis
3%
Irritability
3%
Pain in extremity
3%
Arthralgia
3%
Seborrhoeic dermatitis
3%
Decreased appetite
3%
Hypertension
3%
Anogenital dysplasia
3%
Musculoskeletal pain
3%
Seasonal allergy
3%
Constipation
3%
Odynophagia
3%
Pruritus
3%
Rhinitis allergic
3%
Catarrh
3%
Blood creatine phosphokinase increased
2%
Abdominal discomfort
2%
Eye pruritus
2%
Proctitis
2%
Secondary syphilis
2%
Sinus congestion
2%
Viral upper respiratory tract infection
2%
Fungal infection
2%
Anal fissure
2%
Lipase increased
2%
Musculoskeletal chest pain
2%
Injection site discolouration
2%
Gastrooesophageal reflux disease
2%
Anal chlamydia infection
2%
Abdominal pain upper
2%
Migraine
2%
Intertrigo
2%
Hypersomnia
2%
Proctitis chlamydial
2%
Viral infection
2%
Injection site haematoma
2%
Tinea pedis
2%
Pharyngitis streptococcal
2%
Oral herpes
2%
Acute sinusitis
2%
Faeces soft
2%
Hypoaesthesia
2%
Depressed mood
2%
Abnormal dreams
2%
Acne
2%
Rash maculo-papular
2%
Dysuria
2%
Hypercholesterolaemia
2%
Balanoposthitis
2%
Conjunctivitis allergic
2%
Arthropod bite
2%
Tooth infection
2%
Acarodermatitis
2%
Herpes virus infection
2%
Oropharyngeal gonococcal infection
2%
Muscle spasms
2%
Anxiety disorder
2%
Lymphogranuloma venereum
2%
Night sweats
2%
Skin induration
2%
Dry skin
2%
Papule
2%
Vitamin D deficiency
2%
Genital lesion
2%
Vertigo
1%
Haematospermia
1%
Allergic sinusitis
1%
Nephrolithiasis
1%
Muscular weakness
1%
Temperature intolerance
1%
Otitis media
1%
Pleuritic pain
1%
Pneumonia
1%
Discomfort
1%
Gastroenteritis norovirus
1%
Compression fracture
1%
Muscle contracture
1%
Kaposi's sarcoma
1%
Flushing
1%
Deafness
1%
Abdominal pain lower
1%
Flatulence
1%
Chronic sinusitis
1%
Gastritis
1%
Aphthous stomatitis
1%
Myocardial infarction
1%
Stress at work
1%
Fungal skin infection
1%
Anal pruritus
1%
Affect lability
1%
Synovial cyst
1%
Transaminases increased
1%
Pain
1%
Herpes simplex
1%
Haematuria
1%
Prostatitis
1%
Blastocystis infection
1%
Gingival oedema
1%
Exposure to communicable disease
1%
Weight increased
1%
Leukocytosis
1%
Mitral valve incompetence
1%
Extremity contracture
1%
Hyperkeratosis
1%
Nasal congestion
1%
Malaise
1%
Lymphadenopathy
1%
Nephropathy toxic
1%
Bronchitis bacterial
1%
Spirochaetal infection
1%
Osteochondrosis
1%
Hepatitis C
1%
Umbilical hernia
1%
Parosmia
1%
Abscess
1%
Abscess limb
1%
Epididymitis
1%
Orchitis
1%
Neck pain
1%
Suicide attempt
1%
Anal abscess
1%
Skin infection
1%
Tinea versicolour
1%
Injection site rash
1%
Injection site reaction
1%
Injection site hypoaesthesia
1%
Memory impairment
1%
Urethritis chlamydial
1%
Pilonidal cyst
1%
Carbuncle
1%
Diarrhoea infectious
1%
Lice infestation
1%
Rectal discharge
1%
Impetigo
1%
Visceral leishmaniasis
1%
Anal ulcer
1%
Large intestine polyp
1%
Perianal erythema
1%
Vagus nerve disorder
1%
Rectal haemorrhage
1%
Apathy
1%
Abnormal behaviour
1%
Erosive duodenitis
1%
Tongue discolouration
1%
Sciatica
1%
Nightmare
1%
Sleep disorder
1%
Initial insomnia
1%
Mood swings
1%
Personality disorder
1%
Dyspnoea
1%
Tachyphrenia
1%
Urticaria
1%
Onycholysis
1%
Dermatitis
1%
Dermatitis contact
1%
Hyperhidrosis
1%
Dermatitis allergic
1%
Rhinorrhoea
1%
Chronic obstructive pulmonary disease
1%
Joint dislocation
1%
Limb injury
1%
Wound
1%
Psoriasis
1%
Epicondylitis
1%
Asthma
1%
Ligament sprain
1%
Carbohydrate intolerance
1%
Blepharitis
1%
Foot fracture
1%
Keratitis
1%
Blood creatinine increased
1%
Eosinophil count decreased
1%
Lymphocyte count increased
1%
Eosinophilia
1%
Vitamin B complex deficiency
1%
Conjunctival haemorrhage
1%
Hypertensive heart disease
1%
Hypertriglyceridaemia
1%
Ventricular dyskinesia
1%
Testis discomfort
1%
Multiple allergies
1%
Erythema of eyelid
1%
Tympanic membrane perforation
1%
Vision blurred
1%
Erectile dysfunction
1%
Tachycardia
1%
Tympanic membrane disorder
1%
Hand fracture
1%
Chills
1%
Groin pain
1%
Oral candidiasis
1%
Osteomyelitis
1%
Aphonia
1%
Ligament rupture
1%
Allergy to arthropod bite
1%
Secretion discharge
1%
Acute tonsillitis
1%
Anal infection
1%
Anorectal human papilloma virus infection
1%
Hordeolum
1%
Furuncle
1%
Paraesthesia
1%
Libido decreased
1%
Skin lesion
1%
Alopecia areata
1%
Oropharyngeal pain
1%
Hepatic steatosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance Period)
CAB 30 mg+ABC/3TC QD (Maintenance Period)
CAB 30 mg+ABC/3TC QD (Induction Period)
CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance Period)
Tshireletso Trial Design
1Treatment groups
Experimental Treatment
Group I: CAB-LA PrEPExperimental Treatment1 Intervention
Following a negative HIV test, long-acting Cabotegravir Injection (CAB-LA) 600mg will be administered as a 3mL intramuscular (IM) injection in the gluteal muscle at enrollment, 1 month, and then every 2 months, for a maximum of 13 injections over 24 months of follow up.
Find a Location
Who is running the clinical trial?
Beth Israel Deaconess Medical CenterLead Sponsor
837 Previous Clinical Trials
13,009,772 Total Patients Enrolled
1 Trials studying Pre-Exposure Prophylaxis
88 Patients Enrolled for Pre-Exposure Prophylaxis
Botswana Harvard AIDS Institute PartnershipOTHER
12 Previous Clinical Trials
25,645 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,965 Previous Clinical Trials
2,672,297 Total Patients Enrolled
4 Trials studying Pre-Exposure Prophylaxis
2,303 Patients Enrolled for Pre-Exposure Prophylaxis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking medication such as carbemazapine or St. John's wort.I am able to follow a treatment plan that requires injections every 8 weeks.I am a mother, over 18, and can consent to participate.I weigh less than 35kg.I am under 30 years old or have been pregnant less than 3 times.I have a skin condition that affects the safety of getting shots in my muscle.I am currently being treated for or suspected to have tuberculosis.
Research Study Groups:
This trial has the following groups:- Group 1: CAB-LA PrEP
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How hazardous is CAB-LA PrEP for individuals using this preventive medication?
"The safety of CAB-LA Prep was rated a 3, as Phase 4 trials typically indicate the approval of this therapeutic approach."
Answered by AI
What aims is this medical study striving to achieve?
"The ViiV Healthcare trial sponsor reports that the primary outcome to be monitored over a two-year period will be uptake of CAB-LA injections. Secondary outcomes include infant cabotegravir levels, median maternal weight change and obesity (BMI >30) at 24 months."
Answered by AI
Is recruitment currently available for this investigation?
"According to clinicaltrials.gov, this specific medical study is not presently recruiting participants. The trial was listed on October 1st 2023 and the information was last updated on August 3rd 2023. Meanwhile, there are 56 other trails actively seeking patients at present time."
Answered by AI
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