HIV-1-infectionPhase 2DRIVE-2NCT03589027
Darunavir and Rilpivirine Interactions With Levonorgestrel Implant
A Phase 2 study testing Levonorgestrel two rod sub-dermal implant, Rilpivirine and Darunavir+Ritonavir in people with HIV-1-infection and Contraception, run by Makerere University at 1 site in Uganda.
Trial summary
This study will evaluate the pharmacokinetic properties of Rilpivirine and Darunavir when used in combination with Levonorgestrel Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- HIV-1-infection, Contraception
- What is being tested?
- Levonorgestrel two rod sub-dermal implant, Rilpivirine and Darunavir+Ritonavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUganda
- Study dates
- 7 Aug 2018to Jun 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study.
- Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Women age 18 years to 45 years
- Diagnosed with HIV infection
- Medically eligible for the LNG subdermal implant as a contraceptive method based on the WHO Medical Eligibility Criteria for Contraceptive Use11
- Receiving EFV- or LPV/r-based ART for a minimum of 1 year
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- If not abstinent, must agree to use an effective non-hormonal method of contraception for the duration of the study including male and female condoms or the copper-T intrauterine device.
- Participants must have a negative urine pregnancy test at entry and report no unprotected sex since the last menstrual period or in the last two weeks.
- -
Who cannot join
- HIV RNA greater than 50 copies/mL at the screening visit
- CD4 count below 200 cells/mm3 at the screening visit
- History of virologic failure on the current regimen (two consecutive viral load results equal to or greater than 400 copies/mL)
- Serum hemoglobin less than 9.0 g/dl at screening
- Elevations in serum levels of alanine transaminase (ALT) above 5 times the upper limit of normal
- Elevations in serum creatinine above 2.5 times the upper limit of normal
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- Use of drugs known to be contraindicated with LNG, RPV (for women taking EFV-based ART), or DRV (for women taking LPV-based ART) within 30 days of study entry. Due to the dynamic nature of drug interactions related to antiretroviral therapy, the study team will review all concomitant medications at screening based on the US Department of Health and Human Services drug interaction table 14 and the University of Liverpool HIV drug interaction tables (www.hiv-druginteractions.org)
- Currently pregnant or postpartum <30 days at study entry.
- Breastfeeding women within 6 months of delivery.
- Patients with a history of hypersensitivity to LNG implant, undiagnosed vaginal bleeding, diagnosed or suspected sex hormone dependent neoplasia, benign or malignant liver tumor, or thromboembolic disease.
- Presence of any active clinically significant disease or life-threatening disease that, in the investigator's opinion, would compromise the subject's safety or outcome of the study.
- -
Trial locations and contacts
1 site in 1 country.
Uganda1 site, 1 recruiting
- Recruiting
Infectious Diseases Institue
Kampala, 256
Stephen Research Manager, 0392878652, sokoboi@idi.co.ug
Mohammed Lamorde, PhD
About this study
Official title: A Pharmacokinetic Evaluation of Levonorgestrel Implant in HIV-Infected Women on Darunavir Versus Rilpivirine-based Antiretroviral Therapy
This study will evaluate the pharmacokinetic properties of Rilpivirine and Darunavir when used in combination with Levonorgestrel
Read the detailed description
Despite the benefits of hormonal contraceptives, significant drug-drug interactions (DDIs) with some antiretroviral therapies (ART) represent a barrier to effective family planning methods for HIV-infected women. It is therefore critical to generate data on the combined use of hormonal contraceptives and ART. This study is a prospective, non-randomized, open-label, parallel, two-group, sparse-sampling pharmacokinetic (PK) study to describe levonorgestrel (LNG) PK parameters in two treatment groups (rilpivirine or darunavir- based ART) in 60 HIV-1 infected women. The primary endpoint is the comparison of the mean LNG concentrations at month 6 between the rilpivirine or darunavir treatment groups versus historical controls. This study will provide information on effective ART options for HIV positive women who opt for the contraceptive implant as a family planning method of choice.
- Conditions
- HIV-1-infection, Contraception
- Being tested
- Levonorgestrel two rod sub-dermal implant, Rilpivirine, Darunavir+Ritonavir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levonorgestrel two rod sub-dermal implantDrug
Also called Levonorgestrel, Jadelle
Levonorgestrel (75 mg/rod), 2 rods (150 mg) inserted subdermally
RilpivirineDrug
Also called Edurant
Oral ripilvirine 25mg once daily
Darunavir+RitonavirDrug
Also called DRV/r
Oral DRV/r 600/100mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| Rilpivirine arm | Experimental | All subjects will be administered oral rilpivirine 25mg once daily together with the rest of their oral antiretroviral combination plus a levonorgestrel two-rod subdermal implant (75mg/rod) through out the study period Receives: Drug: Levonorgestrel two rod sub-dermal implant; Drug: Rilpivirine |
| Darunavir arm | Experimental | All subjects will be administered oral darunavir/ritonavir 600/100mg twice daily together with the rest of their oral antiretroviral combination plus a levonorgestrel two-rod subdermal implant (75mg/rod) through out the study period Receives: Drug: Levonorgestrel two rod sub-dermal implant; Drug: Darunavir+Ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levonorgestrel concentrations: Change in mean levonorgestrel (LNG) concentrations
Comparison of the mean levonorgestrel (LNG) concentrations at month 6 between the rilpivirine (RPV) or darunavir (DRV) treatment groups versus historical controls
Measured: 6 months
Secondary outcomes (3)
Change in mean rilpivirine concentration
Rilpivirine mean concentration change prior to implant placement and then over the duration of the study time period.
Measured: 12 months
Change in mean darunavir concentration
Darunavir mean concentration change prior to implant placement and then over the duration of the study time period.
Measured: 12 months
Adverse events
Any signs and symptoms related to hormone exposure, including abnormal vaginal bleeding and local or systemic adverse events observed during the study period in both study groups.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start7 Aug 2018
- Primary completionJun 2019 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, non-randomized, open-label, parallel, two-group, sparse-sampling pharmacokinetic (PK) study to describe levonorgestrel (LNG) PK parameters in two treatment groups (Rilpivirine or Darunavir- based ART) in 60 HIV-1 infected women.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nebraska, University of Pittsburgh, University of Liverpool
- Responsible party
- Principal investigator, Infectious Diseases Institute, Makerere University
- Investigators
- Mohammed Lamorde, PhD, Principal investigator, Infectious Diseases Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03589027
- Sponsor's protocol ID
- PK22
- Acronym
- DRIVE-2
- Status last verified
- Mar 2019
- First submitted
- 29 May 2018
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic Evaluation of Levonorgestrel Implant in HIV-Infected Women on Darunavir Versus Rilpivirine-based Antiretroviral Therapy
- ClinicalTrials.gov ID
- NCT03589027
- Acronym / sponsor ID
- DRIVE-2 / PK22
- Conditions
- HIV-1-infection, Contraception
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Collaborators
- University of Nebraska, University of Pittsburgh, University of Liverpool
- Study start
- 7 Aug 2018 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 17 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the pharmacokinetic properties of Rilpivirine and Darunavir when used in combination with Levonorgestrel
Detailed description
Despite the benefits of hormonal contraceptives, significant drug-drug interactions (DDIs) with some antiretroviral therapies (ART) represent a barrier to effective family planning methods for HIV-infected women. It is therefore critical to generate data on the combined use of hormonal contraceptives and ART. This study is a prospective, non-randomized, open-label, parallel, two-group, sparse-sampling pharmacokinetic (PK) study to describe levonorgestrel (LNG) PK parameters in two treatment groups (rilpivirine or darunavir- based ART) in 60 HIV-1 infected women. The primary endpoint is the comparison of the mean LNG concentrations at month 6 between the rilpivirine or darunavir treatment groups versus historical controls. This study will provide information on effective ART options for HIV positive women who opt for the contraceptive implant as a family planning method of choice.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A prospective, non-randomized, open-label, parallel, two-group, sparse-sampling pharmacokinetic (PK) study to describe levonorgestrel (LNG) PK parameters in two treatment groups (Rilpivirine or Darunavir- based ART) in 60 HIV-1 infected women.
| Arm | Type | Receives |
|---|---|---|
| Rilpivirine arm | Experimental | Drug: Levonorgestrel two rod sub-dermal implant, Drug: RilpivirineAll subjects will be administered oral rilpivirine 25mg once daily together with the rest of their oral antiretroviral combination plus a levonorgestrel two-rod subdermal implant (75mg/rod) through out the study period |
| Darunavir arm | Experimental | Drug: Levonorgestrel two rod sub-dermal implant, Drug: Darunavir+RitonavirAll subjects will be administered oral darunavir/ritonavir 600/100mg twice daily together with the rest of their oral antiretroviral combination plus a levonorgestrel two-rod subdermal implant (75mg/rod) through out the study period |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study.
- Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Women age 18 years to 45 years
- Diagnosed with HIV infection
- Medically eligible for the LNG subdermal implant as a contraceptive method based on the WHO Medical Eligibility Criteria for Contraceptive Use11
Key exclusion criteria (12 listed)
- HIV RNA greater than 50 copies/mL at the screening visit
- CD4 count below 200 cells/mm3 at the screening visit
- History of virologic failure on the current regimen (two consecutive viral load results equal to or greater than 400 copies/mL)
- Serum hemoglobin less than 9.0 g/dl at screening
- Elevations in serum levels of alanine transaminase (ALT) above 5 times the upper limit of normal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levonorgestrel two rod sub-dermal implantAlso: Levonorgestrel, JadelleLevonorgestrel (75 mg/rod), 2 rods (150 mg) inserted subdermally | Drug | Darunavir arm, Rilpivirine arm |
| RilpivirineAlso: EdurantOral ripilvirine 25mg once daily | Drug | Rilpivirine arm |
| Darunavir+RitonavirAlso: DRV/rOral DRV/r 600/100mg twice daily | Drug | Darunavir arm |
Primary outcome
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
3 secondary outcomes
Change in mean rilpivirine concentration
Time frame: 12 months
Change in mean darunavir concentration
Time frame: 12 months
Adverse events
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammed Lamorde, PhD principal investigator
Infectious Diseases Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Levonorgestrel two rod sub-dermal implant, Rilpivirine and Darunavir+Ritonavir in people with HIV-1-infection and Contraception, run by Makerere University at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Senior Research Manager (0704817590, sokoboi@idi.co.ug), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levonorgestrel concentrations: Change in mean levonorgestrel (LNG) concentrations (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2019.