Clinical study on Tolerability and pharmacokinetics of Albuvirtide injection in HIV-infected patients

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2011
INTERVENTION: 160mg Group 1:Placebo:2, 160mg Albuvirtide: 6;320mg Group 3:320mg Albuvirtide: 6;20mg Group:Placebo:2, 20mg Albuvirtide: 6;320mg Group 1:Placebo:2, 320mg Albuvirtide: 8;160mg Group 2:160mg Albuvirtide: 6;80mg Group:Placebo:2, 80mg Albuvirtide: 6;160mg Group 2:160mg Albuvirtide: 6; CONDITION: AIDS PRIMARY OUTCOME: Lab test (hematology, biochemistry, CD4+ cell count, virus loads, urine analysis); INCLUSION CRITERIA: 1. HIV antibody test is positive or possessing HIV medical card; 2. Male and female patients aged 18 to 45 years old; 3. CD4+ cell count>=250/ul, virus load>=5000copies/ml; 4. Body weight >=40 kg and BMI is between 18 to 27 kg/m2; No severe hepatic or renal dysfunction, albumin and other routine health check is normal; 5. Patients are non‐users of cigarette or alcohol, or agree stopping smoking and drinking during the trial; 6. Patients did not receive any anti‐hepatitis virus medicine. Patients should not receive anti‐HIV medicine or have stopped over half year.7.Patients voluntarily signed the informed consent.
Epistemonikos ID: 73ddda71d0f471b2150e80bf3f8e1983b1bb6ad1
First added on: Aug 22, 2024