HIV/AIDSNCT04463784
Efficacy of Efavirenz 400mg vs. 600mg Combined With Lamivudine and Tenofovir in Treatment Naive HIV Infection
A study testing Efavirenz 400Mg Oral Tablet and Efavirenz 600Mg Oral Tablet in people with HIV/AIDS and Mental Impairment, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The present study will be a randomized controlled study in which 500 treatment-naive HIV patients will be randomized 1:1 to Efaviren 400mg v.s. 600mg combined with lamivudine and tenofovir. The whole cohort will be followed for two years. Efficacy and safety of each regimen will be evaluated throughout the study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV/AIDS, Mental Impairment
- What is being tested?
- Efavirenz 400Mg Oral Tablet and Efavirenz 600Mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2018to Aug 2021
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- Willingness and availability to engage in study activities for the duration of the study
- Age between 18-65
- Documented HIV-1 infection (confirmed by Western blot)
- Received no prior antiretroviral therapy
Who cannot join
- Pregnancy or breastfeeding or anticipated pregnancy in two years
- History of AIDS-defining illness
- Hemoglobin < 9g/dl；or peripheral white blood cell counts < 2000/μl；or neutrophil counts < 1000 /μl；or platelet count < 75,000/μl；
- Liver disease (transaminase and alkaline phosphatase levels more than three times the upper limit of the normal range (ULN), bilirubin level more than 2.5 times the ULN)
- Chronic kidney disease (serum creatinine level more than 1.5 times the ULN)
- Patients with a history of injection drug usage
- Patients with a history of mental disorders
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: Peking Union Medical College Hospital
The present study will be a randomized controlled study in which 500 treatment-naive HIV patients will be randomized 1:1 to Efaviren 400mg v.s. 600mg combined with lamivudine and tenofovir. The whole cohort will be followed for two years. Efficacy and safety of each regimen will be evaluated throughout the study.
Read the detailed description
As efaviren has been commonly used as the first-line therapy in HIV infection worldwide, its major side effect i.e. the mental effects have been noticed and has a major influence on the adherence and efficacy of ART regimen. Mental effects of efaviren have been especially critical in Chinese patients, as the effective and toxic ranges of efaviren plasma concentration in Chinese patients are very close to each other.
In this study, 500 treatment-naive Chinese patients with a body weight < 60kg will be screened and recruited. Patients will be randomized 1:1 to efaviren 400mg v.s. 600mg combined with lamivudine and tenofovir. All patients will be followed regularly for 2 years, at 0, 2w, 4w, 3m and every 3 months. Virological and immunological measurements will be done at each visit. Meanwhile, various mental scales will be performed at each visit to evaluate the mental effects of each arm.
- Conditions
- HIV/AIDS, Mental Impairment
- Being tested
- Efavirenz 400Mg Oral Tablet, Efavirenz 600Mg Oral Tablet
- 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.
Efavirenz 400Mg Oral TabletDrug
The experimental arm will receive 400mg efavirenz per randomization with other two antiretroviral medication (tenofovir and lamivudine).
Efavirenz 600Mg Oral TabletDrug
The active comparator arm will receive 600mg efavirenz per randomization with other two antiretroviral medication (tenofovir and lamivudine).
| Study group | Role | What they receive |
|---|---|---|
| Efavirenz 400MG Oral Tablet | Experimental | Recruited treatment-naive HIV infected patients will be given Lamivudin 300mg per day, tenofovir 300mg per day and efavirenz 400mg per day as antiretroviral treatment. Receives: Drug: Efavirenz 400Mg Oral Tablet |
| Efavirenz 600MG Oral Tablet | Active comparator | Recruited treatment-naive HIV infected patients will be given Lamivudin 300mg per day, tenofovir 300mg per day and efavirenz 600mg per day, per standard dose. Receives: Drug: Efavirenz 600Mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Virological measurements at 12 weeks
Plasma viral load
Measured: 12 weeks
Change from Baseline Virological measurements at 24 weeks
Plasma viral load
Measured: 24 weeks
Change from Baseline Virological measurements at 48 weeks
Plasma viral load
Measured: 48 weeks
Change from Baseline Virological measurements at 72 weeks
Plasma viral load
Measured: 72 weeks
Change from Baseline Virological measurements at 96 weeks
Plasma viral load
Measured: 96 weeks
Change from Baseline Immunological measurements at 12 weeks
CD4 T cell count
Measured: 12 weeks
Change from Baseline Immunological measurements at 24 weeks
CD4 T cell count
Measured: 24 weeks
Change from Baseline Immunological measurements at 48 weeks
CD4 T cell count
Measured: 48 weeks
Change from Baseline Immunological measurements at 72 weeks
CD4 T cell count
Measured: 72 weeks
Change from Baseline Immunological measurements at 96 weeks
CD4 T cell count
Measured: 96 weeks
Secondary outcomes (3)
Adverse effects measured by Dizziness Handicap Inventory
Measure statistically significant difference in perception of dizziness by administering the Dizziness Handicap Inventory (DHI) between two groups at different time point. The 25-item tool comprises three sub-scales: physical (DHI-P; 7 items), emotional (DHI-E; 9 items), and functional (DHI-F; 9 items) and each item is scored from 0 to 4. Grading standard: 0-30 points is defiend as minor obstacles, 31-60 points as moderate obstacle, and 61-100 points as serious obstacle with high risk of falling.
Measured: 0, 12, 24, 48, 72, 96 weeks
Adverse effects measured by Hamilton Depression Scale-24
Measure statistically significant difference in perception of depression by administering the Hamilton Depression Scale-24 (HAMD-24) between two groups at different time point. The Hamilton Depression Rating Scale (HAMD) has a total of 24 items. 14 items were scored from 0 to 4, and 10 items were scored from 0 to 2. The total score that less than 8 points is defined as no depression, 8 to 20 points as may be depression, scores that more than 20 is defined as mild or moderate depression, and more than 35 points as severe depression.
Measured: 0, 12, 24, 48, 72, 96 weeks
Adverse effects measured by Pittsburgh Sleep Quality Index
Measure statistically significant difference in perception of sleep quality by administering the Pittsburgh Sleep Quality Index (PSQI) between two groups at different time point. PSQI was used to assess the sleep quality of subjects in the last month. It consists of 19 self-evaluation items and 5 other evaluation items, of which only 18 self-evaluation items participate in scoring. 18 items constitute 7 components, and each component is scored according to 0 ~ 3 grades. The PSQI total score ranges from 0 to 21. The higher the score indicates the worser sleep quality.
Measured: 0, 12, 24, 48, 72, 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start1 Apr 2018
- Primary completionDec 2020 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LI Taisheng, Peking Union Medical College Hospital
- Investigators
- Taisheng Li, PhD, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04463784
- Sponsor's protocol ID
- CACT 1809
- Status last verified
- Jul 2020
- First submitted
- 15 Jul 2018
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hang Q, Ziyan W, Xiaojing S, Min W, Haibo D, Hanhui Y, Zhihao M, Shenghua H, Yun H, Linghua L, Yinzhong S, Yong X, Ping M, Taisheng L. Efavirenz 400 vs 600 mg combined with lamivudine and tenofovir in treatment-naive HIV-infected patients in China: A randomized, multi-centered, controlled trial. Int J Infect Dis. 2026 Sep;170:108859. doi: 10.1016/j.ijid.2026.108859. Epub 2026 Jun 2.
PubMed 42235914Tongtong Y, Shenghua H, Yin W, Lin C, Huanxia L, Chunrong L, Ruifeng Z, Xiaojing Y, Yuan Y, Yuanhong H, Ke Y. Effectiveness and Safety of Dolutegravir Versus Efavirenz-Based Antiviral Regimen in People Living With HIV-1 in Sichuan Province of China: A Real-World Study. J Acquir Immune Defic Syndr. 2022 Oct 1;91(S1):S1-S7. doi: 10.1097/QAI.0000000000003041.
PubMed 36094508
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peking Union Medical College Hospital
- ClinicalTrials.gov ID
- NCT04463784
- Acronym / sponsor ID
- CACT 1809
- Conditions
- HIV/AIDS, Mental Impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 9 Jul 2020 (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.
The present study will be a randomized controlled study in which 500 treatment-naive HIV patients will be randomized 1:1 to Efaviren 400mg v.s. 600mg combined with lamivudine and tenofovir. The whole cohort will be followed for two years. Efficacy and safety of each regimen will be evaluated throughout the study.
Detailed description
As efaviren has been commonly used as the first-line therapy in HIV infection worldwide, its major side effect i.e. the mental effects have been noticed and has a major influence on the adherence and efficacy of ART regimen. Mental effects of efaviren have been especially critical in Chinese patients, as the effective and toxic ranges of efaviren plasma concentration in Chinese patients are very close to each other.
In this study, 500 treatment-naive Chinese patients with a body weight < 60kg will be screened and recruited. Patients will be randomized 1:1 to efaviren 400mg v.s. 600mg combined with lamivudine and tenofovir. All patients will be followed regularly for 2 years, at 0, 2w, 4w, 3m and every 3 months. Virological and immunological measurements will be done at each visit. Meanwhile, various mental scales will be performed at each visit to evaluate the mental effects of each arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Efavirenz 400MG Oral Tablet | Experimental | Drug: Efavirenz 400Mg Oral TabletRecruited treatment-naive HIV infected patients will be given Lamivudin 300mg per day, tenofovir 300mg per day and efavirenz 400mg per day as antiretroviral treatment. |
| Efavirenz 600MG Oral Tablet | Active comparator | Drug: Efavirenz 600Mg Oral TabletRecruited treatment-naive HIV infected patients will be given Lamivudin 300mg per day, tenofovir 300mg per day and efavirenz 600mg per day, per standard dose. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provision of signed and dated informed consent form
- Willingness and availability to engage in study activities for the duration of the study
- Age between 18-65
- Documented HIV-1 infection (confirmed by Western blot)
- Received no prior antiretroviral therapy
Key exclusion criteria (7 listed)
- Pregnancy or breastfeeding or anticipated pregnancy in two years
- History of AIDS-defining illness
- Hemoglobin < 9g/dl；or peripheral white blood cell counts < 2000/μl；or neutrophil counts < 1000 /μl；or platelet count < 75,000/μl；
- Liver disease (transaminase and alkaline phosphatase levels more than three times the upper limit of the normal range (ULN), bilirubin level more than 2.5 times the ULN)
- Chronic kidney disease (serum creatinine level more than 1.5 times the ULN)
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 |
|---|---|---|
| Efavirenz 400Mg Oral TabletThe experimental arm will receive 400mg efavirenz per randomization with other two antiretroviral medication (tenofovir and lamivudine). | Drug | Efavirenz 400MG Oral Tablet |
| Efavirenz 600Mg Oral TabletThe active comparator arm will receive 600mg efavirenz per randomization with other two antiretroviral medication (tenofovir and lamivudine). | Drug | Efavirenz 600MG Oral Tablet |
Primary outcome
Change from Baseline Virological measurements at 12 weeks
Time frame: 12 weeks
Plasma viral load
Change from Baseline Virological measurements at 24 weeks
Time frame: 24 weeks
Plasma viral load
Change from Baseline Virological measurements at 48 weeks
Time frame: 48 weeks
Plasma viral load
Change from Baseline Virological measurements at 72 weeks
Time frame: 72 weeks
Plasma viral load
Change from Baseline Virological measurements at 96 weeks
Time frame: 96 weeks
Plasma viral load
Change from Baseline Immunological measurements at 12 weeks
Time frame: 12 weeks
CD4 T cell count
Change from Baseline Immunological measurements at 24 weeks
Time frame: 24 weeks
CD4 T cell count
Change from Baseline Immunological measurements at 48 weeks
Time frame: 48 weeks
CD4 T cell count
Change from Baseline Immunological measurements at 72 weeks
Time frame: 72 weeks
CD4 T cell count
Change from Baseline Immunological measurements at 96 weeks
Time frame: 96 weeks
CD4 T cell count
3 secondary outcomes
Adverse effects measured by Dizziness Handicap Inventory
Time frame: 0, 12, 24, 48, 72, 96 weeks
Adverse effects measured by Hamilton Depression Scale-24
Time frame: 0, 12, 24, 48, 72, 96 weeks
Adverse effects measured by Pittsburgh Sleep Quality Index
Time frame: 0, 12, 24, 48, 72, 96 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
- Derived from this study: PubMed 42235914Hang Q, Ziyan W, Xiaojing S, Min W, Haibo D, Hanhui Y, Zhihao M, Shenghua H, Yun H, Linghua L, Yinzhong S, Yong X, Ping M, Taisheng L. Efavirenz 400 vs 600 mg combined with lamivudine and tenofovir in treatment-naive HIV-infected patients in China: A randomized, multi-centered, controlled trial. Int J Infect Dis. 2026 Sep;170:108859. doi: 10.1016/j.ijid.2026.108859. Epub 2026 Jun 2.
- Derived from this study: PubMed 36094508Tongtong Y, Shenghua H, Yin W, Lin C, Huanxia L, Chunrong L, Ruifeng Z, Xiaojing Y, Yuan Y, Yuanhong H, Ke Y. Effectiveness and Safety of Dolutegravir Versus Efavirenz-Based Antiviral Regimen in People Living With HIV-1 in Sichuan Province of China: A Real-World Study. J Acquir Immune Defic Syndr. 2022 Oct 1;91(S1):S1-S7. doi: 10.1097/QAI.0000000000003041.
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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.
Taisheng Li, PhD, MD principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Efavirenz 400Mg Oral Tablet and Efavirenz 600Mg Oral Tablet in people with HIV/AIDS and Mental Impairment, run by Peking Union Medical College Hospital at 1 site 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 7 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 9 Jul 2020. 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 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.
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?
Change from Baseline Virological measurements at 12 weeks (time frame: 12 weeks). The study lists 10 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 NCT04463784, which also lists 2 linked publications.
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 Jul 2020.