Pharmacokinetic Study of Long-acting Antiretrovirals and Contraceptives in HIV

NCT07516548 | Not Yet Recruiting

• 2 other identifiers: IRB-300013405R01AI155052
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to understand how long-acting injectable cabotegravir (CAB-LA) used for HIV pre-exposure prophylaxis (PrEP) and hormonal contraceptive methods affect each other when used at the same time. Women who are already using CAB-LA or not using PrEP will choose to join one of several groups based on whether they use injectable contraceptive (IM DMPA), an etonogestrel implant, or no hormonal contraceptive. Participants will have study visits every 4 to 12 weeks for up to 12 or 24 weeks after starting a contraceptive method to collect blood samples and measure levels of CAB-LA and hormone concentrations. The study will compare these levels to see if taking CAB-LA changes hormone concentrations or if using hormonal contraception changes CAB-LA drug levels. Safety, side effects, satisfaction, and continuation of CAB-LA PrEP and contraceptive methods will also be evaluated.

Conditions

HIV Infections; Contraception; Drug-drug Interaction; PrEP; Long-acting Injectable Cabotegravir for PrEP

Keywords

Adolescent girls and young women; Injectable cabotegravir; Botswana; Long-acting injectable cabotegravir; Pharmacokinetic study; PrEP; HIV prevention

Outcome Measures

Primary Outcomes (2)

• To evaluate any associations between CAB-LA exposure and hormonal contraceptive use in the three groups of IM DMPA, ETG implant, and non-hormonal method users by generating geometric mean hormone concentrations (Aim 1a)

  Mean hormone concentrations starting at 0 week (when feasible), 4 weeks, 8 weeks, 12 weeks, and 24 weeks, as applicable to the three contraceptive groups, after contraceptive method initiation and at least after receiving 3rd dose of CAB-LA if in the CAB-LA groups.

  0, 4, 8, 12 weeks for IM DMPA; 0, 4, 8, 12, 24 weeks for ETG implant and non-hormonal method users

• To evaluate any associations between hormonal contraceptive exposure and CAB-LA use by generating geometric mean trough CAB-LA concentrations measured immediately prior to dosing of next CAB-LA (Aim 1b)

  Mean trough CAB-LA concentrations prior to next dosing of CAB-LA

  Immediately prior to each scheduled CAB-LA injection

Secondary Outcomes (4)

• Incidence of adverse events associated with CAB-LA and hormonal contraceptive methods (Aim 2a1)

  12 and 24 weeks after contraceptive method initiation

• Participant satisfaction with CAB-LA and hormonal contraceptive method measured by questionnaire (Aim 2a2)

  12 and 24 weeks after contraceptive method initiation

• Continuation rates of CAB-LA and hormonal contraceptive method (Aim 2a3)

  12 and 24 weeks after contraceptive method initiation

• Participants' experiences and decision-making regarding CAB-LA and contraceptive method options assessed by semi-structured interviews (Aim 2b)

  At the end of study participation or up to 12 months after study participation

Study Arms (5)

Group 1: CAB-LA + IM DMPA

Injectable cabotegravir 600mg + intramuscular depo-medroxyprogesterone acetate 150mg (IM DMPA)

Drug: Long-acting injectable cabotegravir (CAB-LA)

Group 2: CAB-LA + ETG implant

Injectable cabotegravir 600mg + etonogestrel (ETG) implant 68mg

Drug: Long-acting injectable cabotegravir (CAB-LA)

Group 3: CAB-LA + no hormonal method

Injectable cabotegravir 600mg + no hormonal method

Drug: Long-acting injectable cabotegravir (CAB-LA)

Group 4: No PrEP + IM DMPA

No PrEP + intramuscular depot medroxyprogesterone acetate (IM DMPA) 150mg

Other: No PrEP

Group 5: No PrEP + ETG implant

No PrEP + etonogestrel (ETG) implant 68mg

Other: No PrEP

Interventions

No PrEP OTHER

No HIV pre-exposure prophylaxis administered

Group 4: No PrEP + IM DMPA; Group 5: No PrEP + ETG implant

Long-acting injectable cabotegravir (CAB-LA) DRUG

Injectable cabotegravir 600 mg administered as long-acting HIV pre-exposure prophylaxis (PrEP).

Group 1: CAB-LA + IM DMPA; Group 2: CAB-LA + ETG implant; Group 3: CAB-LA + no hormonal method

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult females aged 18 years or older who are HIV-seronegative

You may qualify if:

• Female 18 years of age or older and willing and able to provide an informed consent
• \< 14 days after delivery (calendar day of birth = day 0)
• Negative HIV screening test (conducted at the time of enrolment)
• Female \<30 years old or has had \< 3 prior pregnancies (Gravida 1, 2, or 3 including this pregnancy)
• Plan to stay and receive postpartum and pediatric care in the Gaborone or Molepolole region for 24 months

You may not qualify if:

• Receiving carbamazepine, phenobarbital, phenytoin, oxycarbazepine, rifampin, rifabutin, rifapentine, systemic dexamethasone (\>1 dose oral/IV), or St. John's wort
• Suspected to have, recently diagnosed with, or on treatment for TB (due to interaction with rifampicin)
• Previous hypersensitivity reaction to CAB or other INSTI
• Unstable medical or psychiatric condition making it unlikely they will be able to adhere to injections every 2 months
• Plan for pediatric and post-partum care outside the government system (private clinics)
• Inflammatory skin condition that compromises the safety of the intramuscular injection
• Weight \<35kg
• if HIV-uninfected or unknown HIV status, willing to be tested for HIV
• if HIV-infected, documented to be on DTG as part of an antiretroviral treatment regimen
• maternal age \>18 years,
• ability to speak English or Setswana
• intend to be available for follow up in Molepolole, Gaborone or Mochudi for 18 months post-delivery
• have access to a cell phone (including phone of friend or relative)
• did not attend antenatal care or were not included in Tsepamo surveillance
• maternal age \<18,

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• University of Alabama at Birmingham: lead
• University of Nebraska: collaborator
• Beth Israel Deaconess Medical Center: collaborator
• Botswana Harvard Health Partnership: collaborator

Study Sites (1)

Princess Marina Hospital

Bontleng, Gaborone, Botswana

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Rena Patel, MD, MPH, MPhil

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Rebecca Zash

  Division of Infectious Disease Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rena Patel, MD, MPH

CONTACT

205.934.8145; renapatel@uabmc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: April 8, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-05

Locations

BO (1)