NCT03589027 (DRIVE-2) is a Phase 2 clinical trial of Levonorgestrel two rod sub-dermal implant in HIV-1-infection, sponsored by Makerere University.

Who is sponsoring NCT03589027?

NCT03589027 is sponsored by Makerere University.

What drugs are being tested in NCT03589027?

Interventions in NCT03589027: Levonorgestrel two rod sub-dermal implant, Rilpivirine, Darunavir+Ritonavir.

What condition does NCT03589027 study?

NCT03589027 studies HIV-1-infection, Contraception.

Is NCT03589027 still recruiting?

NCT03589027 is currently status unknown. Last updated 26 March 2019.

Last reviewed 2019-03-26 · How we verify

NCT03589027: DRIVE-2

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

A Pharmacokinetic Evaluation of Levonorgestrel Implant in HIV-Infected Women on Darunavir Versus Rilpivirine-based Antiretroviral Therapy

Status unknown Phase 2 Last updated 26 March 2019

What this trial tests

Phase 2 trial testing Levonorgestrel two rod sub-dermal implant in HIV-1-infection in 60 participants. Status unknown.

Timeline

7 August 2018

Primary endpoint
1 June 2019

1 June 2020

Quick facts

Lead sponsor	Makerere University
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	7 August 2018
Primary completion	1 June 2019
Estimated completion	1 June 2020
Sites	1 location across Uganda

Drugs / interventions tested

Levonorgestrel two rod sub-dermal implant — full drug profile →
Rilpivirine — full drug profile →
Darunavir+Ritonavir

Conditions studied

HIV-1-infection — all drugs for HIV-1-infection →
Contraception — all drugs for Contraception →

Sponsor

Makerere University

Who can join

Adults 18 to 45, female only, with HIV-1-infection or Contraception. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Levonorgestrel concentrations: Change in mean levonorgestrel (LNG) concentrations
Time frame: 6 months
Comparison of the mean levonorgestrel (LNG) concentrations at month 6 between the rilpivirine (RPV) or darunavir (DRV) treatment groups versus historical controls

Sponsor's own description

This study will evaluate the pharmacokinetic properties of Rilpivirine and Darunavir when used in combination with Levonorgestrel

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Pharmacokinetics of levonorgestrel and etonogestrel contraceptive implants over 48 weeks with rilpivirine- or darunavir-based antiretroviral therapy.
Nakalema S, Chappell CA, Pham M, Byakika-Kibwika P, et al · · 2022 · cited 8× · PMID 36059130 · DOI 10.1093/jac/dkac296

Verify or expand the search:

Other recruiting trials for HIV-1-infection

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Other Makerere University trials

Trials by the same sponsor.

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NCT06139198 — Self-management Intervention for Reducing Epilepsy Burden Among Ugandans With Epilepsy. · NA · recruiting
NCT06791928 — Peer Delivered HIV/Syphilis Self-Testing With Assisted Partner Notification Services · Phase 2 · enrolling by invitation
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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 NCT03589027 (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 Makerere University
Last refreshed: 26 March 2019

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/NCT03589027.

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