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Cisgender Females for HIV (Human Immunodeficiency Virus)

N/A
Recruiting
Research Sponsored by Midway Specialty Care 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 weeks 20, 44 and 92
Awards & highlights

Study Summary

Oral PrEP regimens (FTC/TDF have been the mainstay of HIV prevention however patients now have more options for HIV prevention. In addition to oral PrEP regimens, the FDA approved the use of long acting Cabotegravir (CAB-LA) as the first long-acting medication for HIV prevention. This study will evaluate real world clinical outcomes of cisgender female patients who start CAB-LA for PrEP.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 20, 44 and 92
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 20, 44 and 92 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Describe the percent of cisgender females persistent on CAB-LA over 44 weeks.
Secondary outcome measures
Describe incidence of bacterial STIs through weeks 20, 44 and 92
Describe percentage adherence to CAB-LA injection schedule at weeks 20, 44 and 92 for cisgender females
Describe percentage adherence to CAB-LA injection schedule at weeks 20, 44 and 92 for cisgender females with substance use and/or unstable housing.
+3 more

Side effects data

From 2023 Phase 2 trial • 309 Patients • NCT02120352
92%
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%
Proctalgia
3%
Ear infection
3%
Abdominal distension
3%
Cellulitis
3%
Musculoskeletal stiffness
3%
Urethritis
3%
Dyspepsia
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%
Gingival oedema
1%
Muscle contracture
1%
Kaposi's sarcoma
1%
Weight increased
1%
Flushing
1%
Deafness
1%
Abdominal pain lower
1%
Flatulence
1%
Chronic sinusitis
1%
Blastocystis infection
1%
Gastritis
1%
Aphthous stomatitis
1%
Leukocytosis
1%
Mitral valve incompetence
1%
Myocardial infarction
1%
Stress at work
1%
Fungal skin infection
1%
Anal pruritus
1%
Affect lability
1%
Exposure to communicable disease
1%
Synovial cyst
1%
Transaminases increased
1%
Pain
1%
Herpes simplex
1%
Haematuria
1%
Prostatitis
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)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Cisgender FemalesExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Midway Specialty Care CenterLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Cisgender Female Patients Who Start on Long Acting Cabotegravir for PrEP
2024. "Cisgender Female Patients Who Start on Long Acting Cabotegravir for PrEP". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06145854.
~67 spots leftby Oct 2026
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