PrEP and ARTNCT03620734
Study to Determine Interaction Between the Use of Feminizing Hormone Therapy and Antiretroviral Agents Concomitantly Among Transgender Women
An observational study of PrEP and ART, run by Thai Red Cross AIDS Research Centre at 1 site in Thailand.
Trial summary
Objective 1. To determine pharmacokinetic (PK) DDI between GAHT and ARVs used as PrEP and ART among TGW 2. To evaluate ARV adherence among TGW Read more about this study
- Who is it for?
- Ages 18 to 40 years, men only
- Conditions the study is for
- PrEP and ART
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- 30 Nov 2017to 1 Oct 2019
- Phase
- Observational
- 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 40 years
- Men only
- Adult
Study population: transgender women (TGW)
Who may be able to join
- Thai nationality
- Age 18-40 years old
- Male-to-female transgender individual
- PrEP/ART naïve
- Body mass index 18.5-25 kg/m2
- Calculated creatinine clearance (CrCl) ≥60 mL/min, as estimated by the Cockcroft- Gault equation
- Alanine aminotransferase (ALT) ≤2.5 x ULN
- Have signed the informed consent form
Who cannot join
- Known history of allergy to hormonal or ARV component to be used in the study
- Male-to-female transgender who underwent orchiectomy
- Any of the following in HIV-infected participants
- CD4 < 350 cells/mm3
- History of psychiatric disorder that may be worsening by taking EFV
- Previous use of injectable GAHT in the past 6 months
Show all 13Show fewer
- Current use of any of the following medication:
- Anticonvulsant: Phenytoin, carbamazepine or phenobarbitol
- Ergot-containing agents: dihydroergotamine, ergotamine or other ergot derivatives
- Sedatives: Midazolam or triazolam
- Herbs: Gingko biloba, St John's wort or milk thistle
- Anti-infective agents: Erythromycin, clarithromycin, ketoconazole, itraconazole, rifampicin or rifabutin
- Alcohol or drug use that, in the opinion of the investigator, would interfere with completion of study procedures
Trial locations and contacts
1 site in 1 country.
Thailand1 site
The Thai Red Cross AIDS Research Centre
Ratchadamri, Bangkok, 10330
About this study
Official title: The Thai Red Cross AIDS Research Centre
Objective
- To determine pharmacokinetic (PK) DDI between GAHT and ARVs used as PrEP and ART among TGW
- To evaluate ARV adherence among TGW
Read the detailed description
GAHT will be initiated on week 0. ARVs, either PrEP or ART, will be initiated on week 3. GAHT will then be withheld on week 5, and restart at week 8.
GAHT: Oral estradiol valerate 2 mg once daily and cyproterone acetate 25 mg once daily, which are the treatment of choice for GAHT in the TRC-ARC's Tangerine Community Health Center, will be provided to all participants.
PrEP and ART regimen: Generic fixed-dose combination of TDF 300 mg and FTC 200 mg will be used for PrEP and a generic fixed-dose combination of TDF 300 mg, FTC 200 mg and efavirenz 600 mg will be used for ART as recommended in the 2017 Thailand National Guidelines on HIV/AIDS Treatment and Prevention.
- Conditions
- PrEP and ART
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| GAHT and PrEP | HIV-negative TGW will have HIV testing using the 4th generation immunoassays/nucleic acid testing (NAT) in acute HIV testing algorithm currently used at the Thai Red Cross Anonymous Clinic at week 5, 8, and 15. Creatinine clearance will be performed at week 15. | |
| GAHT and ART | HIV-positive TGW on ART will have their plasma HIV RNA measured at the same day ART is initiated and at week 15 (12 weeks after ART provision). CD4 count will be measure at week 15. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric mean (%CV) area under the plasma concentration time curve from 0 to 24 hours (AUC0-24) of estradiol
Measured: Measured at week 3 and week 5 of the study period
Geometric mean (%CV) area under the plasma concentration time curve from 0 to 24 hours (AUC0-24) of tenofovir
Measured: Measured at week 5 and week 8 of the study period
Geometric mean (%CV) maximum plasma concentration (Cmax) of estradiol
Measured: Measured at week 3 and week 5 of the study period
Geometric mean (%CV) maximum plasma concentration (Cmax) of tenofovir
Measured: Measured at week 5 and week 8 of the study period
Geometric mean (%CV) trough plasma concentration (C24) of estradiol
Measured: Measured at week 3 and week 5 of the study period
Geometric mean (%CV) trough plasma concentration (C24) of tenofovir
Measured: Measured at week 5 and week 8 of the study period
Geometric mean (%CV) half-life (t1/2) of estradiol
Measured: Measured at week 3 and week 5 of the study period
Geometric mean (%CV) half-life (t1/2) of tenofovir
Measured: Measured at week 5 and week 8 of the study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start30 Nov 2017
- Primary completion1 Oct 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PrEP and ARTStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thai Red Cross AIDS Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nittaya Phanuphak, MD, PhD, Principal investigator, Thai Red Cross AIDS Research Centre (TRCARC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03620734
- Sponsor's protocol ID
- iFACT
- Status last verified
- Oct 2019
- First submitted
- 31 May 2018
- Last updated
- 9 Oct 2019
- Results posted
- No
Publications
Hiransuthikul A, Janamnuaysook R, Himmad K, Kerr SJ, Thammajaruk N, Pankam T, Phanjaroen K, Mills S, Vannakit R, Phanuphak P, Phanuphak N; iFACT Study Team. Drug-drug interactions between feminizing hormone therapy and pre-exposure prophylaxis among transgender women: the iFACT study. J Int AIDS Soc. 2019 Jul;22(7):e25338. doi: 10.1002/jia2.25338.
PubMed 31298497
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Thai Red Cross AIDS Research Centre
- ClinicalTrials.gov ID
- NCT03620734
- Acronym / sponsor ID
- iFACT
- Conditions
- PrEP and ART
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Thai Red Cross AIDS Research CentreUniversity, hospital or other
- Study start
- 30 Nov 2017 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 8 Aug 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.
Objective
- To determine pharmacokinetic (PK) DDI between GAHT and ARVs used as PrEP and ART among TGW
- To evaluate ARV adherence among TGW
Detailed description
GAHT will be initiated on week 0. ARVs, either PrEP or ART, will be initiated on week 3. GAHT will then be withheld on week 5, and restart at week 8.
GAHT: Oral estradiol valerate 2 mg once daily and cyproterone acetate 25 mg once daily, which are the treatment of choice for GAHT in the TRC-ARC's Tangerine Community Health Center, will be provided to all participants.
PrEP and ART regimen: Generic fixed-dose combination of TDF 300 mg and FTC 200 mg will be used for PrEP and a generic fixed-dose combination of TDF 300 mg, FTC 200 mg and efavirenz 600 mg will be used for ART as recommended in the 2017 Thailand National Guidelines on HIV/AIDS Treatment and Prevention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GAHT and PrEP | – | –HIV-negative TGW will have HIV testing using the 4th generation immunoassays/nucleic acid testing (NAT) in acute HIV testing algorithm currently used at the Thai Red Cross Anonymous Clinic at week 5, 8, and 15. Creatinine clearance will be performed at week 15. |
| GAHT and ART | – | –HIV-positive TGW on ART will have their plasma HIV RNA measured at the same day ART is initiated and at week 15 (12 weeks after ART provision). CD4 count will be measure at week 15. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Age groups
- Adult
- Study population
- transgender women (TGW)
Key inclusion criteria (8 listed)
- Thai nationality
- Age 18-40 years old
- Male-to-female transgender individual
- PrEP/ART naïve
- Body mass index 18.5-25 kg/m2
Key exclusion criteria (13 listed)
- Known history of allergy to hormonal or ARV component to be used in the study
- Male-to-female transgender who underwent orchiectomy
- Any of the following in HIV-infected participants
- Previous use of injectable GAHT in the past 6 months
- Current use of any of the following medication:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Geometric mean (%CV) area under the plasma concentration time curve from 0 to 24 hours (AUC0-24) of estradiol
Time frame: Measured at week 3 and week 5 of the study period
Geometric mean (%CV) area under the plasma concentration time curve from 0 to 24 hours (AUC0-24) of tenofovir
Time frame: Measured at week 5 and week 8 of the study period
Geometric mean (%CV) maximum plasma concentration (Cmax) of estradiol
Time frame: Measured at week 3 and week 5 of the study period
Geometric mean (%CV) maximum plasma concentration (Cmax) of tenofovir
Time frame: Measured at week 5 and week 8 of the study period
Geometric mean (%CV) trough plasma concentration (C24) of estradiol
Time frame: Measured at week 3 and week 5 of the study period
Geometric mean (%CV) trough plasma concentration (C24) of tenofovir
Time frame: Measured at week 5 and week 8 of the study period
Geometric mean (%CV) half-life (t1/2) of estradiol
Time frame: Measured at week 3 and week 5 of the study period
Geometric mean (%CV) half-life (t1/2) of tenofovir
Time frame: Measured at week 5 and week 8 of the study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2019.
- Derived from this study: PubMed 31298497Hiransuthikul A, Janamnuaysook R, Himmad K, Kerr SJ, Thammajaruk N, Pankam T, Phanjaroen K, Mills S, Vannakit R, Phanuphak P, Phanuphak N; iFACT Study Team. Drug-drug interactions between feminizing hormone therapy and pre-exposure prophylaxis among transgender women: the iFACT study. J Int AIDS Soc. 2019 Jul;22(7):e25338. doi: 10.1002/jia2.25338.
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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.
Nittaya Phanuphak, MD, PhD principal investigator
Thai Red Cross AIDS Research Centre (TRCARC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PrEP and ART, run by Thai Red Cross AIDS Research Centre at 1 site in Thailand.
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 8 inclusion and 13 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: finished, as of the sponsor's last update on 9 Oct 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 Thailand. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Geometric mean (%CV) area under the plasma concentration time curve from 0 to 24 hours (AUC0-24) of estradiol (time frame: Measured at week 3 and week 5 of the study period). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03620734, which also lists 1 linked publication.
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 9 Oct 2019.