HIV InfectionsPhase 4OATNCT02935075
Optimization of Antiretroviral Therapy
A Phase 4 study testing Tenofovir disoproxil fumarate, Lamivudine and Efavirenz in people with HIV Infections, run by Shanghai Public Health Clinical Center at 3 sites in China.
Trial summary
The combination antiretroviral therapy (cART) inhibit HIV replication effectively. However, synergy among these drugs has not been well considered. The dose of drugs used as monotherapy is the same as that used in combination therapy. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Tenofovir disoproxil fumarate, Lamivudine and Efavirenz
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 3 sitesChina
- Study dates
- 5 Mar 2018to 31 Aug 2019
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- HIV antibody positive
- Chinese nationality
- Naïve to antiretroviral therapy
- Willing to start antiretroviral therapy
- Provision of written informed consent
Who cannot join
- Pregnant, breastfeeding, or lactating
- Females try to get pregnant during the research period
- Subjects who allergic to any of the research drugs
- Subjects that taking other drugs that known to impact the absorption, distribution, metabolism and excretion of the research drugs
- Any serious or active medical or psychiatric illness which, in the opinion of the Investigator, would interfere with treatment, assessment, compliance with the protocol, or subject safety. This would include any active clinically significant renal, cardiac, pulmonary, vascular, or metabolic (thyroid disorders, adrenal disease) illness, or malignancy
- Medical or psychiatric condition or occupational responsibilities that may preclude compliance with the protocol
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- Laboratory blood values:
- Haemoglobin <9.0 grams/decilitre (g/dL)
- Neutrophil count <1500/mm3
- Platelet count <75,000/mm3
- Aspartate aminotransferase or Alanine transaminase >3 times Upper Limit of Normal (ULN)
- Total bilirubin >3 times Upper Limit of Normal (ULN)
- Subjects with an estimated creatinine clearance of <90 mL/minute
Trial locations and contacts
3 sites in 1 country.
China3 sites
Yunnan AIDS care center
Kunming, Yunnan, 650041
The Second Hospital of Nanjing
Nanjing, Jiangsu, 210003
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, 201508
About this study
The combination antiretroviral therapy (cART) inhibit HIV replication effectively. However, synergy among these drugs has not been well considered. The dose of drugs used as monotherapy is the same as that used in combination therapy. Tenofovir+lamivudine+efavirenz is still the first line regimen of cART in developing countries. The side effects of these drugs are related to the concentration of drugs. Based on our previous data, we aim to evaluate whether reduce the dose of tenofovir and efavirenz could decreasing the incidence of the side effects while not scarifying their virological efficacy.
- Conditions
- HIV Infections
- Being tested
- Tenofovir disoproxil fumarate, Lamivudine, Efavirenz
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir disoproxil fumarateDrug
Oral daily
LamivudineDrug
Oral daily
EfavirenzDrug
Oral daily
| Study group | Role | What they receive |
|---|---|---|
| Reduced dose | Experimental | Tenofovir 200mg +lamivudine 300mg +efavirenz 400mg PO q.d. Receives: Drug: Tenofovir disoproxil fumarate; Drug: Lamivudine; Drug: Efavirenz |
| Standard dose | Active comparator | Tenofovir 300mg +lamivudine 300mg +efavirenz 600mg PO q.d. Receives: Drug: Tenofovir disoproxil fumarate; Drug: Lamivudine; Drug: Efavirenz |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with HIV viral road < 50 copies/ml
calculate the percentage of patients who with HIV viral road <50 copies/ml every month in two groups
Measured: 48 weeks
Secondary outcomes (1)
Cell Differentiation 4 (CD4) T cell counts
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study start5 Mar 2018
- Primary completion5 Jun 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Public Health Clinical Center
- Sponsor type
- Other government
- Collaborators
- Yunnan Provincial Infectious Disease Hospital, The Second Hospital of Nanjing Medical University
- Responsible party
- Principal investigator, Hongzhou Lu, Shanghai Public Health Clinical Center
- Investigators
- Hongzhou Lu, Principal investigator, Shanghai Public Health Clinical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02935075
- Sponsor's protocol ID
- 2016-M-1
- Acronym
- OAT
- Status last verified
- Feb 2020
- First submitted
- 14 Oct 2016
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Antiretroviral Therapy
- ClinicalTrials.gov ID
- NCT02935075
- Acronym / sponsor ID
- OAT / 2016-M-1
- Conditions
- HIV Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Shanghai Public Health Clinical CenterOther government
- Collaborators
- Yunnan Provincial Infectious Disease Hospital, The Second Hospital of Nanjing Medical University
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 5 Jun 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 17 Oct 2016 (estimated)
- 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.
The combination antiretroviral therapy (cART) inhibit HIV replication effectively. However, synergy among these drugs has not been well considered. The dose of drugs used as monotherapy is the same as that used in combination therapy. Tenofovir+lamivudine+efavirenz is still the first line regimen of cART in developing countries. The side effects of these drugs are related to the concentration of drugs. Based on our previous data, we aim to evaluate whether reduce the dose of tenofovir and efavirenz could decreasing the incidence of the side effects while not scarifying their virological efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reduced dose | Experimental | Drug: Tenofovir disoproxil fumarate, Drug: Lamivudine, Drug: EfavirenzTenofovir 200mg +lamivudine 300mg +efavirenz 400mg PO q.d. |
| Standard dose | Active comparator | Drug: Tenofovir disoproxil fumarate, Drug: Lamivudine, Drug: EfavirenzTenofovir 300mg +lamivudine 300mg +efavirenz 600mg PO q.d. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- HIV antibody positive
- Chinese nationality
- Naïve to antiretroviral therapy
- Willing to start antiretroviral therapy
- Provision of written informed consent
Key exclusion criteria (13 listed)
- Pregnant, breastfeeding, or lactating
- Females try to get pregnant during the research period
- Subjects who allergic to any of the research drugs
- Subjects that taking other drugs that known to impact the absorption, distribution, metabolism and excretion of the research drugs
- Any serious or active medical or psychiatric illness which, in the opinion of the Investigator, would interfere with treatment, assessment, compliance with the protocol, or subject safety. This would include any active clinically significant renal, cardiac, pulmonary, vascular, or metabolic (thyroid disorders, adrenal disease) illness, or malignancy
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 |
|---|---|---|
| Tenofovir disoproxil fumarateOral daily | Drug | Reduced dose, Standard dose |
| LamivudineOral daily | Drug | Reduced dose, Standard dose |
| EfavirenzOral daily | Drug | Reduced dose, Standard dose |
Primary outcome
Percentage of patients with HIV viral road < 50 copies/ml
Time frame: 48 weeks
calculate the percentage of patients who with HIV viral road <50 copies/ml every month in two groups
1 secondary outcome
Cell Differentiation 4 (CD4) T cell counts
Time frame: 48 weeks
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 18 Feb 2020.
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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.
Hongzhou Lu principal investigator
Shanghai Public Health Clinical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tenofovir disoproxil fumarate, Lamivudine and Efavirenz in people with HIV Infections, run by Shanghai Public Health Clinical Center at 3 sites in China.
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 5 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 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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?
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?
Percentage of patients with HIV viral road < 50 copies/ml (time frame: 48 weeks). 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 18 Feb 2020.