HIV/AIDS
Conditions
Keywords
Simplified Therapy Regimen, Real World Study, HIV-1-infected patients
Brief summary
To observe the efficacy and safety of simplified therapy regimen for treating with HIV-1 infected patients in Chinese real word.
Detailed description
This is an phase IV open-label, multicenter, single-arm clinical trial in. A total of 600 cases were planned to be recruited. These cases were given simplified therapy regimen of lopinavir (200mg) and ritonavir (50mg) (500mg, oral, bid ) combined with lamivudine (300mg, oral, qd. The observation duration is thirty-sixth months. Patients will be followed up before and 12, 24 and 36 months after receiving the simplified regimen, observing the viral inhibition rate and the change of CD4 cell count, the safety and patients'compliance.
Interventions
DRUGLpv/r+3TC
It is a simplified therapy regimen study of lopinavir and ritonavir combined with lamivudine for HIV-1 infected patients in the real world of China.
Sponsors
Guiyang Public Health Clinical Center
The Third People's Hospital of Kunming
The Second People's Hospital of Nanjing
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
The Third People's Hospital of Guilin
Guangxi Longtan hospital
The Fourth People's Hospital of Nanning
LiuZhou People's Hospital
Tianjin Second People's Hospital
The Sixth People's Hospital of Shenyang
The Sixth People's Hospital of Henan
The Sixth People's Hospital of Xinjiang
The Eighth People's Hospital of Xi'an
Guangzhou 8th People's Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. HIV-1 infection confirmed 2. Agree to use simplified therapy regimen. 3. Agree to detect CD4 count at least once per half a year
Exclusion criteria
1. Have participated in HIV vaccine clinical trial or other drug trials in the past three months. 2. Patients who could not complete the scheduled follow-up (such as weakness and poor compliance). 3. Patients who have the history of resistance or allergy to LPV/r or 3TC.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of virus inhibition | 36 Months | the ratio of HIV RNA\< 50 copies/mL at 12, 24 or 36 months after treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The immunological ability | 36 Months | the count of CD4 cells |
Other
| Measure | Time frame | Description |
|---|---|---|
| The level of compliance | 36 Months | To explicit the number of people who have completed the treatment |
Countries
China
Contacts
Primary ContactLinghua Li, Doctor
Backup ContactWeiping Cai, Bachelor
Outcome results
None listed