Efficacy and Safety of Tenofovir Plus Lamivudine Plus Efavirenz Regimen as First-line Antiretroviral Therapy
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| ClinicalTrials.gov Identifier: NCT01844297 |
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Recruitment Status
: Unknown
Verified April 2013 by LI Taisheng, Peking Union Medical College.
Recruitment status was: Not yet recruiting
First Posted
: May 1, 2013
Last Update Posted
: May 1, 2013
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| AIDS/HIV PROBLEM | Drug: TDF+3TC+EFV | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 500 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (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 |
| Study Start Date : | May 2013 |
| Estimated Primary Completion Date : | October 2015 |
| Estimated Study Completion Date : | December 2015 |
| Arm | Intervention/treatment |
|---|---|
| TDF+3TC+EFV | Drug: TDF+3TC+EFV |
- Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48 [ Time Frame: 48 weeks ]
- Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96 [ Time Frame: 96 weeks ]
- Percentage of Participants With HIV-1 RNA < 40 Copies/mL at Week 96 [ Time Frame: 96 weeks ]
- Change From Baseline in CD4 count at Week 48 [ Time Frame: Baseline and 48 weeks ]
- Change From Baseline in CD4 count at Week 96 [ Time Frame: Baseline and 96 weeks ]
- Incidence of adverse events and laboratory abnormalities from baseline to week 48 [ Time Frame: 48 weeks ]
- Incidence of adverse events and laboratory abnormalities from baseline to week 96 [ Time Frame: 96 weeks ]
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01844297
| Contact: Tai sheng Li, MD | 86-10-69155086 | litsh@263.net |
| 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 | |
| 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 |
| First Posted: | May 1, 2013 Key Record Dates |
| Last Update Posted: | May 1, 2013 |
| Last Verified: | April 2013 |
Additional relevant MeSH terms:
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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 |