A Phase 4 interventional study of Every 4-week long-acting injectable cabotegravir and rilpivirine and Every 4-week long-acting injectable cabotegravir and rilpivirine in HIV -1 Infection, sponsored by International Maternal Pediatric Adolescent AIDS Clinical Trials Group. Recruiting at 10 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by International Maternal Pediatric Adolescent AIDS Clinical Trials Group · Phase 4, Interventional, and Treatment
Phase IV, multi-site, open-label, non-randomized study of the pharmacokinetics (PK) of long-acting injectable cabotegravir and rilpivirine (CAB LA + RPV LA) during pregnancy and postpartum.
Up to 40 adult-participants with HIV viral suppression will be enrolled, in pairs with their infants, to achieve 30 evaluable adult-participants overall. The study will include women who initiated CAB LA + RPV LA outside the study, prior to study entry, either pre-conception (including on the day of conception) or post-conception.
International Maternal Pediatric Adolescent AIDS Clinical Trials Group is the lead sponsor of 27 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pregnant women with controlled HIV who were using CAB LA + RPV LA pre-conception, and continue to receive Q4W CAB LA + RPV LA
Drug: Every 4-week long-acting injectable cabotegravir and rilpivirine
Pregnant women with controlled HIV who switch from oral SOC and initiate Q4W CAB LA + RPV LA post-conception, and continue to receive CAB LA + RPV LA
Drug: Every 4-week long-acting injectable cabotegravir and rilpivirine
Long-acting injectable cabotegravir and rilpivirine, initiated pre-conception. Participants will receive these drugs as prescribed outside the study by their non-study clinical care provider.
Long-acting injectable cabotegravir and rilpivirine, initiated post-conception. Participants will receive these drugs as prescribed outside the study by their non-study clinical care provider.
Population PK: geometric mean clearance of CAB and RPV in second trimester, third trimester, and postpartum derived from a population PK model
Population PK: geometric mean clearance of CAB and RPV in second trimester, third trimester, and postpartum derived from a population PK model
Time frame: Measured from study entry through six weeks postpartum
Geometric mean pharmacokinetic trough of CAB and RPV from every 4 week (Q4W) CAB LA and RPV LA measured every 4 weeks in plasma in second trimester, third trimester, and postpartum
Geometric mean pharmacokinetic trough of CAB and RPV from every 4 week (Q4W) CAB LA and RPV LA measured every 4 weeks in plasma in second trimester, third trimester, and postpartum
Time frame: Measured from study entry through six weeks postpartum
Percentage of adult participants with HIV RNA less than 50 copies/mL at delivery
Percentage of adult participants with HIV RNA less than 50 copies/mL at delivery
Time frame: Delivery
Percentage of adult participants with virologic escape
Percentage of adult participants with virologic escape, defined as a single measurement of HIV RNA greater than or equal to 200 copies/mL
Time frame: Measured from study entry through six weeks postpartum
Percentage of adult participants with confirmed virologic failure
Percentage of adult participants with confirmed virologic failure, defined as two successive HIV RNA test results greater than or equal to 200 copies/mL from separate specimens collected at least two weeks apart
Time frame: Through 6 weeks postpartum
Number of adult participants with HIV resistance to CAB or RPV who had confirmed virologic failure
Number of adult participants with HIV resistance to CAB or RPV using IAS-USA, in participants who experienced confirmed virologic failure
Time frame: Through 6 weeks postpartum
Number of infant participants with perinatal transmission
Number of infant participants with perinatal transmission
Time frame: Birth and six weeks post-birth
Percentage of adult participants with at least one Grade 3 or higher adverse event
Percentage of adult participants with at least one Grade 3 or higher adverse event
Time frame: Measured from study entry through six weeks postpartum
Percentage of adult participants with at least one serious adverse event
Percentage of adult participants with at least one serious adverse event
Time frame: Measured from study entry through six weeks postpartum
Percentage of infant participants with at least one serious adverse event
Percentage of infant participants with at least one serious adverse event
Time frame: Measured from birth through six weeks post-birth
Percentage of adult participants with spontaneous abortion
Percentage of adult participants with spontaneous abortion less than 20 weeks gestation
Time frame: Through 6 weeks postpartum
Percentage of adult participants with fetal demise/stillbirth
Percentage of adult participants with fetal demise/stillbirth, at greater than or equal to 20 weeks gestation
Time frame: Through 6 weeks postpartum
Percentage of infant participants born small for gestational age
Percentage of infant participants born small for gestational age, where birthweight is less than 10th percentile for sex and gestational age assigned at birth, based on Intergrowth 21st Standards
Time frame: Birth
Percentage of infant participants with low birth weight
Percentage of infant participants with low birth weight, defined as less than 2500 grams
Time frame: Birth
Percentage of infant participants born preterm
Percentage of infant participants born preterm, defined as less than 37 weeks gestation
Time frame: Birth
Percentage of mother-infant pairs with occurrence of any adverse pregnancy outcome
Percentage of mother-infant pairs with occurrence of any adverse pregnancy outcome. Outcomes include: spontaneous abortion (\<20 weeks gestation), stillbirth (≥20 weeks gestation), preterm delivery (\<37 gestational weeks), small for gestational age (\<10th percentile per INTERGROWTH 21st Standards), or neonatal death
Time frame: Through 6 weeks postpartum
Percentage of infant participants with a congenital anomaly
Percentage of infant participants with a congenital anomaly based on the Metropolitan Atlanta Congenital Defects Program (MACDP) definition of defect
Time frame: Birth
Percentage of infant deaths
Percentage of infant deaths
Time frame: Measured from birth through six weeks post-birth
Percentage of adult participants who would recommend CAB LA and RPV LA injections for other people living with HIV during pregnancy
Percentage of adult participants who would recommend CAB LA and RPV LA injections
Time frame: Six weeks postpartum
Plan to share: Yes — Individual participant data that underlie results in the publication, after deidentification.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 3 months following publication and available throughout period of funding of the International Maternal Pediatric Adolescent AIDS Clinical Trial (IMPAACT) Network by NIH.
Access criteria: With whom? Researchers who provide a methodologically sound proposal for use of the data that is approved by the IMPAACT Network. For what types of analyses? To achieve aims in the proposal approved by the IMPAACT Network. By what mechanism will data be made available? Researchers may submit a request for access to data using the IMPAACT "Data Request" form at: https://www.impaactnetwork.org/studies/submit-research-proposal. Researchers of approved proposals will need to sign an IMPAACT Data Use Agreement before receiving the data.
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for Apr 2028, 18 months after the start.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 3, 2026: primary completion Mar 2028 → Apr 2028 and completion Mar 2028 → Apr 2028.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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International Maternal Pediatric Adolescent AIDS Clinical Trials Group