Human Immunodeficiency VirusPhase 4CODANCT04910711
Investigating the Interaction Between Two Long-acting Reversible Methods of Contraception and Dolutegravir, a Treatment for HIV
A Phase 4 study testing Dolutegravir, Levonorgestrel implant and Depo medroxyprogesterone acetate injection in people with Human Immunodeficiency Virus and Contraception, run by Botswana Harvard AIDS Institute Partnership at 1 site in Botswana.
Trial summary
It is important to make sure that women have access to effective methods of contraception to prevent pregnancy so that they can make choices about when and if they will have their first or next child. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus, Contraception, ART
- What is being tested?
- Dolutegravir, Levonorgestrel implant and Depo medroxyprogesterone acetate injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteBotswana
- Study dates
- 21 Oct 2021to 31 Oct 2024
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sex female
- Age 18-45 years
- Desire to use LNG implant (for at least 6 months) or for at least one cycle of use of DMPA injectable (3 months), following comprehensive client-centered contraceptive counselling
- Willing and able to initiate the LNG implant or the DMPA injectable at enrolment visit or soon thereafter
- Participants who are engaging in sexual activity that could lead to pregnancy must agree to use a non-hormonal method of contraception, in addition to the LNG implant or DMPA injectable, while participating in the study. Acceptable contraceptives include: condoms (male or female); diaphragm or cervical cap with spermicide; non-hormonal intrauterine device; bilateral tubal ligation; and male partner vasectomy
- No acute infections or other opportunistic diseases requiring systemic medication of hospitalisation within 14 days prior to study entry
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- The following laboratory values:
- Haemoglobin ≥8.0 g/dL
- Creatinine clearance >60 mL/min/1.73m2
- Aspartate transaminase (AST; serum glutamic oxaloacetic transaminase (SGOT)) <2.5 x upper limit of normal ULN
- Alanine transaminase (ALT; serum glutamic pyruvic transaminase (SGPT)) <2.5 x ULN
- Platelet count ≥50,000 platelets/mm3
- Last menstrual period ≤35 days prior to study entry
- No sexual activity that could lead to pregnancy since last menstrual period without contraception (condoms, male or female); diaphragm or cervical cap with spermicide; non-hormonal intrauterine device; bilateral tubal ligation; and male partner vasectomy), as reported by study participant and assessed by study clinician
- Negative serum or urine pregnancy test at screening and study enrolment
- Willing to undergo questionnaires, examinations and phlebotomy per schedule for the duration of the study period
- Able to consent for study participation in English or Setswana
- For HIV-positive participants:
- Documented HIV-1 infection
- Using DTG-based ART (DTG 50mg once daily co-administered with 2 NRTIs (emtricitabine/tenofovir or lamivudine/tenofovir)
- DTG-based ART use (for at least 30 days prior to contraceptive method initiation). On stable regimen containing DTG and 2 NRTIs for ≥ 30 days without gaps in adherence in the last 30 days prior to study entry, and no known plans to change ART regimen for the duration of the study
- Most recent HIV plasma RNA below lower limit of quantitation of the assay used per standard of care
Who cannot join
- Sex male
- Women <18 years
- Any contraindication (WHO Medical Eligibility Criteria for Contraceptive Use Category 3 or 4) to receiving the selected contraceptive method, based on WHO Medical Eligibility Criteria for Contraceptive Use (24)
- Postpartum less than 6 weeks
- Currently breastfeeding
- Currently pregnant or intends to become pregnant during the study
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- The following laboratory values:
- Hemoglobin <8.0 g/dL
- Creatinine clearance ≤60 mL/min/1.73m2
- Aspartate transaminase (AST; SGOT) ≥2.5 x ULN
- Alanine transaminase (ALT; SGPT) ≥2.5 x ULN
- Platelet count <50,000 platelets/mm3
- Receipt of DMPA during the 120 days or norethisterone enanthate (NET-EN) during the 60 days prior to study entry
- Initiated the LNG implant prior to study entry
- Receipt of other hormonal treatments (e.g., oral contraceptives, contraceptive vaginal ring, contraceptive patch, or oral hormone replacement therapy) within the 30 days prior to study entry
- The study puts the participant at unacceptable risk based on the judgment of the study staff
- Known allergy/sensitivity or any hypersensitivity to components of study medication(s) or their formulation
- Active drug or alcohol use or dependence that would interfere with adherence to study requirements
- Concomitant use of drugs known to be contraindicated with LNG or MPA
- Use of any drugs known to: 1) induce CYP3A4 system within 30 days or 2) inhibit the CYP3A4 system with one week prior to enrolment visit
- Use or anticipated use of concomitant enzyme-inducing drugs, including but not limited to rifampicin for tuberculosis treatment and anti-convulsant medications (e.g., phenytoin, carbamazepine, barbiturates, primidone, topiramate, oxcarbazepine, felbamate)
- Unwilling to attend study visits or adhere to study visit procedures
- Unable to consent
- For HIV-positive participants:
- Self-reported non-adherence to ART
- Concomitant use of drugs known to be contraindicated with DTG or medicinal products that reduce DTG exposure (e.g. magnesium/ aluminium-containing antacid, iron and calcium supplements, multivitamins and inducing agents, rifampicin, St. John's wort and anti-epileptic medicinal products carbamazepine, oxcarbazepine, phenytoin and phenobarbital)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Contraceptives and Dolutegravir-based ART
It is important to make sure that women have access to effective methods of contraception to prevent pregnancy so that they can make choices about when and if they will have their first or next child. Some of the most effective methods of contraception are the long-acting, reversible methods of contraception (LARCS), including the contraceptive implant and the contraceptive injection. In areas of the world where there are high numbers of people living with HIV, providing contraception to women is sometimes complicated, as there are known to be interactions between some of the medications that treat HIV and some hormonal methods of contraception. One medication to treat HIV, dolutegravir, is now one of the first-line treatments for HIV in Botswana, and more and more women of childbearing age are taking dolutegravir to treat HIV. At the moment, there is limited information on whether or not there are interactions between dolutegravir (the HIV medication) and the contraceptive implant or the contraceptive injection, two commonly used methods of contraception in Botswana. The main purpose of this study is to find out if women using contraception and also taking dolutegravir have lower levels of contraceptive hormone in their blood compared to women taking no HIV treatment. The study hypothesis is that there is no interaction between dolutegravir and the contraceptive implant or injection.
In this study, levels of hormone from the injection or the implant will be measured in women living with HIV who take dolutegravir and compared to hormone levels in women who do not have HIV and who have never taken any medications to treat HIV. Women will be counselled about all of the possible methods of contraception (including the pill, the injection, the implant and the copper intrauterine device (or coil/loop)) that are available and will be empowered to make their own decision about the method of contraception they feel will be best for them. Women who choose the implant or the injection will be invited to enrol in the study; and will be categorised into one of four groups, based on whether or not they are living with HIV and taking dolutegravir. At several time points, women will have blood tests to check the level of hormone from the implant or the injection, over a course of 12 weeks for women starting the injection and 24 weeks for women starting the implant. Women will also be asked to complete a short questionnaire about any side effects from the contraception including changes to bleeding patterns. At the end of the 12 weeks (for women starting the injection) or 24 weeks (for women starting the implant), the results from these blood samples will be analysed to see how the levels of the hormone in their blood changed over time. The study will also look at whether the levels of dolutegravir (the HIV medication) changed over time. These results will be compared between women living with HIV taking dolutegravir and women without HIV who have never taken dolutegravir to see whether there is any interaction between dolutegravir and the hormonal contraceptive implant or contraceptive injection.
Read the detailed description
This study will evaluate whether dolutegravir (DTG)-based antiretroviral therapy (ART) given with two widely used hormonal contraceptives avoid pharmacokinetic drug-drug interactions that lead to reduced levels of hormonal concentrations and could, thus, reduce contraceptive effectiveness. Two highly effective and commonly used methods of hormonal contraception in African settings will be studied: the levonorgestrel (LNG) sub-dermal contraceptive implant and the depot medroxyprogesterone acetate (DMPA) injectable contraceptive.
Overall, the investigators hypothesise that the plasma concentrations of the studied hormonal contraceptives in women living with HIV-1 and taking DTG-based ART will be equivalent to concentrations in HIV-negative, ART naïve women.
Specific Aims:
Specific Aim 1: To compare plasma LNG concentrations among (a) levonorgestrel contraceptive implant-users in Botswana receiving DTG-based ART and (b) HIV-negative, ART naïve levonorgestrel contraceptive implant users.
Specific Aim 2: To compare plasma medroxyprogesterone acetate (MPA) concentrations among (a) DMPA injectable-users in Botswana receiving DTG-based ART and (b) HIV-negative, ART naïve DMPA injectable users.
Specific Aim 3: To compare the trough plasma concentrations of DTG before and after contraceptive use to understand how LNG and DMPA may affect DTG exposure.
Specific Aim 4: To determine if the LNG implant and DMPA injectable inhibit ovulation in the presence of DTG.
Specific Aim 5: To evaluate safety, tolerability, bleeding patterns and contraceptive method continuation with concomitant LNG implant or DMPA injectable, compared to controls (HIV negative, ART naïve women).
- Conditions
- Human Immunodeficiency Virus, Contraception, ART
- Being tested
- Dolutegravir, Levonorgestrel implant, Depo medroxyprogesterone acetate injection
- Keywords
- Contraception, HIV, Antiretroviral Therapy, Dolutegravir, Drug interactions, Etonogestrel implant, Contraceptive implant, DMPA injection, Contraceptive injection
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DolutegravirDrug
Dolutegravir-based antiretroviral therapy
Levonorgestrel implantDrug
Women initiating the levonorgestrel implant
Depo medroxyprogesterone acetate injectionDrug
Women initiating the depo medroxyprogesterone acetate injection
| Study group | Role | What they receive |
|---|---|---|
| DTG/LNG | Active comparator | Receiving dolutegravir-based antiretroviral therapy and initiating the levonorgestrel implant Receives: Drug: Dolutegravir; Drug: Levonorgestrel implant |
| NEG/LNG | Other | HIV negative, not receiving antiretroviral therapy and initiating the levonorgestrel implant Receives: Drug: Levonorgestrel implant |
| DTG/MPA | Active comparator | Receiving dolutegravir-based antiretroviral therapy and the depot medroxyprogesterone acetate injection Receives: Drug: Dolutegravir; Drug: Depo medroxyprogesterone acetate injection |
| NEG/MPA | Other | HIV negative, not receiving antiretroviral therapy and receiving the depot medroxyprogesterone acetate injection Receives: Drug: Depo medroxyprogesterone acetate injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-week levonorgestrel area under the concentration-time curve (AUC)
The AUC of levonorgestrel over 0-24 weeks will be estimated in women initiating the levonorgestrel implant. The levonorgestrel AUC0-24 weeks will be compared between women living with HIV receiving dolutegravir-based antiretroviral therapy and HIV-negative women who have never taken antiretroviral therapy.
Measured: The AUC0-24 weeks will be calculated at 24 weeks from participant enrolment, using levonorgestrel concentrations measured at 0, 2, 4, 8, 12, 16 and 24 weeks post-levonorgestrel implant initiation.
12-week medroxyprogesterone acetate AUC
The AUC of medroxyprogesterone acetate over 0-12 weeks will be estimated in women initiating the depot medroxyprogesterone acetate injection. The medroxyprogesterone acetate AUC0-12 weeks will be compared between women living with HIV receiving dolutegravir-based antiretroviral therapy and HIV-negative women who have never taken antiretroviral therapy.
Measured: The AUC0-12 weeks will be calculated at 12 weeks from participant enrolment, using medroxyprogesterone acetate concentrations measured at 0, 2, 4, 8, 10 and 12 weeks post-DMPA injection initiation.
Secondary outcomes (6)
Cmin for levonorgestrel, medroxyprogesterone acetate and dolutegravir
Minimum plasma drug concentration (Cmin)
Measured: 24 weeks (LNG) or 12 weeks (MPA)
Cmax for levonorgestrel, medroxyprogesterone acetate and dolutegravir
Maximum plasma drug concentration (Cmax)
Measured: 24 weeks (LNG) or 12 weeks (MPA)
CL/F of levonorgestrel, medroxyprogesterone acetate and dolutegravir
Apparent oral clearance (CL/F)
Measured: 24 weeks (LNG) or 12 weeks (MPA)
Ovulation
Number of participants with endogenous progesterone concentrations above the threshold for ovulation at all time points up to week 24 (LNG) or week 12 (MPA)
Measured: 24 weeks (LNG) or 12 weeks (MPA)
Safety, tolerability, side effects and bleeding patterns
Number of participants with reported adverse events or side effects (e.g. changes to bleeding pattern) over the course of the study.
Measured: 24 weeks (LNG) or 12 weeks (MPA)
Contraception method continuation
Number of participants who chose to continue method of contraception at study completion
Measured: 24 weeks (LNG) or 12 weeks (MPA)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start21 Oct 2021
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency VirusStudies 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 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Botswana Harvard AIDS Institute Partnership
- Sponsor type
- University, hospital or other
- Collaborators
- University of Liverpool
- Responsible party
- Principal investigator, Chelsea Morroni, Botswana Harvard AIDS Institute Partnership
- Investigators
- Chelsea Morroni, PhD MBChB, Principal investigator, Botswana Harvard AIDS Institute Partnership
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04910711
- Sponsor's protocol ID
- UBR/RES/IRB//BIO/236
- Acronym
- CODA
- Status last verified
- Jul 2023
- First submitted
- 24 May 2021
- Last updated
- 27 Jul 2023
- Results posted
- No
- 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 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contraceptives and Dolutegravir-based ART
- ClinicalTrials.gov ID
- NCT04910711
- Acronym / sponsor ID
- CODA / UBR/RES/IRB//BIO/236
- Conditions
- Human Immunodeficiency Virus, Contraception, ART
- Keywords
- Contraception, HIV, Antiretroviral Therapy, Dolutegravir, Drug interactions, Etonogestrel implant, Contraceptive implant, DMPA injection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Botswana Harvard AIDS Institute PartnershipUniversity, hospital or other
- Collaborators
- University of Liverpool
- Study start
- 21 Oct 2021 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 2 Jun 2021 (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.
It is important to make sure that women have access to effective methods of contraception to prevent pregnancy so that they can make choices about when and if they will have their first or next child. Some of the most effective methods of contraception are the long-acting, reversible methods of contraception (LARCS), including the contraceptive implant and the contraceptive injection. In areas of the world where there are high numbers of people living with HIV, providing contraception to women is sometimes complicated, as there are known to be interactions between some of the medications that treat HIV and some hormonal methods of contraception. One medication to treat HIV, dolutegravir, is now one of the first-line treatments for HIV in Botswana, and more and more women of childbearing age are taking dolutegravir to treat HIV. At the moment, there is limited information on whether or not there are interactions between dolutegravir (the HIV medication) and the contraceptive implant or the contraceptive injection, two commonly used methods of contraception in Botswana. The main purpose of this study is to find out if women using contraception and also taking dolutegravir have lower levels of contraceptive hormone in their blood compared to women taking no HIV treatment. The study hypothesis is that there is no interaction between dolutegravir and the contraceptive implant or injection.
In this study, levels of hormone from the injection or the implant will be measured in women living with HIV who take dolutegravir and compared to hormone levels in women who do not have HIV and who have never taken any medications to treat HIV. Women will be counselled about all of the possible methods of contraception (including the pill, the injection, the implant and the copper intrauterine device (or coil/loop)) that are available and will be empowered to make their own decision about the method of contraception they feel will be best for them. Women who choose the implant or the injection will be invited to enrol in the study; and will be categorised into one of four groups, based on whether or not they are living with HIV and taking dolutegravir. At several time points, women will have blood tests to check the level of hormone from the implant or the injection, over a course of 12 weeks for women starting the injection and 24 weeks for women starting the implant. Women will also be asked to complete a short questionnaire about any side effects from the contraception including changes to bleeding patterns. At the end of the 12 weeks (for women starting the injection) or 24 weeks (for women starting the implant), the results from these blood samples will be analysed to see how the levels of the hormone in their blood changed over time. The study will also look at whether the levels of dolutegravir (the HIV medication) changed over time. These results will be compared between women living with HIV taking dolutegravir and women without HIV who have never taken dolutegravir to see whether there is any interaction between dolutegravir and the hormonal contraceptive implant or contraceptive injection.
Detailed description
This study will evaluate whether dolutegravir (DTG)-based antiretroviral therapy (ART) given with two widely used hormonal contraceptives avoid pharmacokinetic drug-drug interactions that lead to reduced levels of hormonal concentrations and could, thus, reduce contraceptive effectiveness. Two highly effective and commonly used methods of hormonal contraception in African settings will be studied: the levonorgestrel (LNG) sub-dermal contraceptive implant and the depot medroxyprogesterone acetate (DMPA) injectable contraceptive.
Overall, the investigators hypothesise that the plasma concentrations of the studied hormonal contraceptives in women living with HIV-1 and taking DTG-based ART will be equivalent to concentrations in HIV-negative, ART naïve women.
Specific Aims:
Specific Aim 1: To compare plasma LNG concentrations among (a) levonorgestrel contraceptive implant-users in Botswana receiving DTG-based ART and (b) HIV-negative, ART naïve levonorgestrel contraceptive implant users.
Specific Aim 2: To compare plasma medroxyprogesterone acetate (MPA) concentrations among (a) DMPA injectable-users in Botswana receiving DTG-based ART and (b) HIV-negative, ART naïve DMPA injectable users.
Specific Aim 3: To compare the trough plasma concentrations of DTG before and after contraceptive use to understand how LNG and DMPA may affect DTG exposure.
Specific Aim 4: To determine if the LNG implant and DMPA injectable inhibit ovulation in the presence of DTG.
Specific Aim 5: To evaluate safety, tolerability, bleeding patterns and contraceptive method continuation with concomitant LNG implant or DMPA injectable, compared to controls (HIV negative, ART naïve women).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DTG/LNG | Active comparator | Drug: Dolutegravir, Drug: Levonorgestrel implantReceiving dolutegravir-based antiretroviral therapy and initiating the levonorgestrel implant |
| NEG/LNG | Other | Drug: Levonorgestrel implantHIV negative, not receiving antiretroviral therapy and initiating the levonorgestrel implant |
| DTG/MPA | Active comparator | Drug: Dolutegravir, Drug: Depo medroxyprogesterone acetate injectionReceiving dolutegravir-based antiretroviral therapy and the depot medroxyprogesterone acetate injection |
| NEG/MPA | Other | Drug: Depo medroxyprogesterone acetate injectionHIV negative, not receiving antiretroviral therapy and receiving the depot medroxyprogesterone acetate injection |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (22 listed)
- Sex female
- Age 18-45 years
- Desire to use LNG implant (for at least 6 months) or for at least one cycle of use of DMPA injectable (3 months), following comprehensive client-centered contraceptive counselling
- Willing and able to initiate the LNG implant or the DMPA injectable at enrolment visit or soon thereafter
- Participants who are engaging in sexual activity that could lead to pregnancy must agree to use a non-hormonal method of contraception, in addition to the LNG implant or DMPA injectable, while participating in the study. Acceptable contraceptives include: condoms (male or female); diaphragm or cervical cap with spermicide; non-hormonal intrauterine device; bilateral tubal ligation; and male partner vasectomy
Key exclusion criteria (26 listed)
- Sex male
- Women <18 years
- Any contraindication (WHO Medical Eligibility Criteria for Contraceptive Use Category 3 or 4) to receiving the selected contraceptive method, based on WHO Medical Eligibility Criteria for Contraceptive Use (24)
- Postpartum less than 6 weeks
- Currently breastfeeding
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 |
|---|---|---|
| DolutegravirDolutegravir-based antiretroviral therapy | Drug | DTG/LNG, DTG/MPA |
| Levonorgestrel implantWomen initiating the levonorgestrel implant | Drug | DTG/LNG, NEG/LNG |
| Depo medroxyprogesterone acetate injectionWomen initiating the depo medroxyprogesterone acetate injection | Drug | DTG/MPA, NEG/MPA |
Primary outcome
24-week levonorgestrel area under the concentration-time curve (AUC)
Time frame: The AUC0-24 weeks will be calculated at 24 weeks from participant enrolment, using levonorgestrel concentrations measured at 0, 2, 4, 8, 12, 16 and 24 weeks post-levonorgestrel implant initiation.
The AUC of levonorgestrel over 0-24 weeks will be estimated in women initiating the levonorgestrel implant. The levonorgestrel AUC0-24 weeks will be compared between women living with HIV receiving dolutegravir-based antiretroviral therapy and HIV-negative women who have never taken antiretroviral therapy.
12-week medroxyprogesterone acetate AUC
Time frame: The AUC0-12 weeks will be calculated at 12 weeks from participant enrolment, using medroxyprogesterone acetate concentrations measured at 0, 2, 4, 8, 10 and 12 weeks post-DMPA injection initiation.
The AUC of medroxyprogesterone acetate over 0-12 weeks will be estimated in women initiating the depot medroxyprogesterone acetate injection. The medroxyprogesterone acetate AUC0-12 weeks will be compared between women living with HIV receiving dolutegravir-based antiretroviral therapy and HIV-negative women who have never taken antiretroviral therapy.
6 secondary outcomes
Cmin for levonorgestrel, medroxyprogesterone acetate and dolutegravir
Time frame: 24 weeks (LNG) or 12 weeks (MPA)
Cmax for levonorgestrel, medroxyprogesterone acetate and dolutegravir
Time frame: 24 weeks (LNG) or 12 weeks (MPA)
CL/F of levonorgestrel, medroxyprogesterone acetate and dolutegravir
Time frame: 24 weeks (LNG) or 12 weeks (MPA)
Ovulation
Time frame: 24 weeks (LNG) or 12 weeks (MPA)
Safety, tolerability, side effects and bleeding patterns
Time frame: 24 weeks (LNG) or 12 weeks (MPA)
Contraception method continuation
Time frame: 24 weeks (LNG) or 12 weeks (MPA)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- 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.
Chelsea Morroni, PhD MBChB principal investigator
Botswana Harvard AIDS Institute Partnership
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dolutegravir, Levonorgestrel implant and Depo medroxyprogesterone acetate injection in people with Human Immunodeficiency Virus and Contraception, run by Botswana Harvard AIDS Institute Partnership at 1 site in Botswana.
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 22 inclusion and 26 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 27 Jul 2023. 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 Botswana. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-week levonorgestrel area under the concentration-time curve (AUC) (time frame: The AUC0-24 weeks will be calculated at 24 weeks from participant enrolment, using levonorgestrel concentrations measured at 0, 2, 4, 8, 12, 16 and 24 weeks post-levonorgestrel implant initiation.). The study lists 2 primary outcomes in all. 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 27 Jul 2023.