NCT06336434 is a Phase 1, PHASE2 clinical trial of CAB LA 600mg in HIV-1-infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Who is sponsoring NCT06336434?

NCT06336434 is sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

What drugs are being tested in NCT06336434?

Interventions in NCT06336434: CAB LA 600mg, RPV LA 900mg, CAB LA 400mg, RPV LA 600mg.

What condition does NCT06336434 study?

NCT06336434 studies HIV-1-infection, Pregnancy, Postpartum.

Is NCT06336434 still recruiting?

NCT06336434 is currently withdrawn. Last updated 31 July 2025.

Last reviewed 2025-07-31 · How we verify

NCT06336434

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy

Withdrawn Phase 1, PHASE2 Last updated 31 July 2025

What this trial tests

Phase 1, PHASE2 trial testing CAB LA 600mg in HIV-1-infection. Withdrawn.

Timeline

1 May 2025

Primary endpoint
30 January 2028

30 January 2028

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 1, PHASE2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Start date	1 May 2025
Primary completion	30 January 2028
Estimated completion	30 January 2028
Sites	8 locations across South Africa, United States

Drugs / interventions tested

CAB LA 600mg — full drug profile →
RPV LA 900mg — full drug profile →
CAB LA 400mg — full drug profile →
RPV LA 600mg — full drug profile →

Conditions studied

HIV-1-infection — all drugs for HIV-1-infection →
Pregnancy — all drugs for Pregnancy →
Postpartum — all drugs for Postpartum →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

18 and older, female only, with HIV-1-infection or Pregnancy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase I/II, multicenter, open-label, non-randomized study with four groups to characterize the pharmacokinetics and safety of Cabotegravir (CAB) and Rilpivirine (RPV) long-acting injectable (LA) during pregnancy and postpartum among people with HIV-1 viral suppression and their infants.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Optimising Paediatric HIV Treatment: Recent Developments and Future Directions.
Kamphuis AEM, Bamford A, Tagarro A, Cressey TR, et al · · 2024 · cited 3× · PMID 39436531 · DOI 10.1007/s40272-024-00656-4
The Promises and Prospects of Long-Acting Therapeutics for Treatment and Prevention of Infectious Diseases.
Olagunju A, Perazzolo S, Stephen ZR, Ryan M, et al · · 2026 · cited 2× · PMID 40956864 · DOI 10.1146/annurev-pharmtox-071724-100739

Verify or expand the search:

Other recruiting trials for HIV-1-infection

Currently open trials in the same condition.

NCT07293559 — Understanding Practices of Lactation and Infant Feeding Together With Women With HIV in the United States · recruiting
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NCT06554717 — Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV · Phase 2 · recruiting
NCT06774872 — Doravirine/Lamivudine (DOR/3TC) as a Maintenance ART in Comparison With Dolutegravir/Lamivudine (DTG/3TC) in PLWH Succes · Phase 2 · recruiting
NCT06890988 — Ending the Epidemic Interventions in the Dental Setting - UH3 · NA · recruiting

Other National Institute of Allergy and Infectious Diseases (NIAID) trials

Trials by the same sponsor.

NCT07216794 — Small Trial of Alendronate Impact on the Reservoir of HIV · Phase 2 · not yet recruiting
NCT07215858 — BPL-1357 Against H1N1 Influenza Virus Challenge · Phase 2 · recruiting
NCT06987318 — A Study to Evaluate the Safety and Antiviral Activity of Two Human Monoclonal Antibodies (VRC07-523LS and PGT121.414.LS) · Phase 1 · not yet recruiting
NCT07124559 — A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of · Phase 1, PHASE2 · not yet recruiting
NCT07342491 — Dasatinib for HIV-1 Reservoir Reduction · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06336434 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID)
Last refreshed: 31 July 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06336434.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing