Efficacy and Safety of Tenofovir Plus Lamivudine Plus Efavirenz Regimen as First-line Antiretroviral Therapy
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2013 by Peking Union Medical College.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Peking Union Medical College
Information provided by (Responsible Party):
LI Taisheng, Peking Union Medical College
ClinicalTrials.gov Identifier:
NCT01844297
First received: August 24, 2012
Last updated: April 26, 2013
Last verified: April 2013
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Purpose
This study aims to evaluate the safety and effectiveness of the tenofovir disoproxil fumarate (TDF) + lamivudine (3TC) + efavirenz (EFV) regimen in antiretroviral therapy (ART)-naive Chinese HIV/AIDS patients.
| Condition | Intervention |
|---|---|
|
AIDS/HIV PROBLEM |
Drug: TDF+3TC+EFV |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Efficacy and Safety of Tenofovir Disoproxil Fumarate Plus Lamivudine Plus Efavirenz Regimen as First-line Antiretroviral Therapy for ART-naive Chinese Patients With HIV-1 Infection |
Resource links provided by NLM:
Further study details as provided by Peking Union Medical College:
Primary Outcome Measures:
- Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48 [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96 [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
- Percentage of Participants With HIV-1 RNA < 40 Copies/mL at Week 96 [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
- Change From Baseline in CD4 count at Week 48 [ Time Frame: Baseline and 48 weeks ] [ Designated as safety issue: No ]
- Change From Baseline in CD4 count at Week 96 [ Time Frame: Baseline and 96 weeks ] [ Designated as safety issue: No ]
- Incidence of adverse events and laboratory abnormalities from baseline to week 48 [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
- Incidence of adverse events and laboratory abnormalities from baseline to week 96 [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 500 |
| Study Start Date: | May 2013 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | October 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| TDF+3TC+EFV | Drug: TDF+3TC+EFV |
Detailed Description:
This study is a prospective, open-label, multi-centered clinical trial to assess the virologic suppression and immune recovery rates as well as tolerability of the regimen 3TC+TDF+EFV in ARV-naive Chinese population.
500 eligible participants will be recruited to take the regimen If the patient fails to tolerate EFV, it can be substituted by NVP when CD4 < 250/μL, and by LPV/r when CD4 > 250/uL. If the patient fails to tolerate TDF, AZT will be an alternative, except when Hb < 90/L or neutrophil count < 0.75×109/L. The participants will be followed up by months 0.5, 1, 2 ,3 and every 3 months subsequently for 2 years.
The efficacy of the regimen will be evaluated by comparison between different points along the time line and previous regimens. The safety of the regimen will be assessed by monitoring kidney function, bone density, cardiovascular profile, lipid profile, liver function etc as well as other adverse events.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- age between 18-65 years of either gender
- HIV-1 antibody seropositive detected by ELISA and confirmed by western blot
- CD4 cell count < 500/ul
- Signed informed consent, with no condition that precludes follow-up for 2 years
- No plan to move out of the area during the trial
- antiretroviral therapy naive
Exclusion Criteria:
- patients in acute phase of HIV infection
- patients with ongoing opportunistic infection or AIDS-related malignancies; or with opportunistic infection within previous 3 months and still unstable within 14 days before inclusion
-
patients with the any of the following test results during screening for inclusion:
- WBC count < 2000/ul,
- neutrophil count < 1000/ul,
- Hb < 9g/dl,
- platelet count < 75000/ul,
- serum creatinine > 1.5 ULN,
- transaminases or alkaline phosphatase > 3 ULN,
- total bilirubin > 2 ULN,
- serum creatinine kinase > 2 ULN
- CCr < 60ml/min
- Pregnancy and breastfeeding
- Intravenous drug user
- Severe neuropathy or mental disorder
- history of alcohol abuse and unable to withdrawal
- Severe peptic ulcer disease
- Non-Chinese nationality
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01844297
Please refer to this study by its ClinicalTrials.gov identifier: NCT01844297
Contacts
| Contact: Tai sheng Li, MD | 86-10-69155086 | litsh@263.net |
Locations
| China, Beijing | |
| Peking Union Medical College Hospital | Not yet recruiting |
| Beijing, Beijing, China, 100730 | |
| Contact: Wei Lv, MD 86-10-69155082 lvweipumch@163.com | |
| Principal Investigator: Taisheng Li, MD | |
Sponsors and Collaborators
Peking Union Medical College
More Information
| Responsible Party: | LI Taisheng, director of the Department of Infectious Disease, Peking Union Medical College |
| ClinicalTrials.gov Identifier: | NCT01844297 History of Changes |
| Other Study ID Numbers: | CACT1215 |
| Study First Received: | August 24, 2012 |
| Last Updated: | April 26, 2013 |
| Health Authority: | China: Ministry of Science and Technology |
Additional relevant MeSH terms:
|
Tenofovir Lamivudine Efavirenz Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Anti-Retroviral Agents Anti-HIV Agents Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 Enzyme Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP3A Inducers |
ClinicalTrials.gov processed this record on September 26, 2016