Pharmacokinetic Study of Albuvirtide and Lopinavir/Ritonavir in HIV-infected Patients

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-TRC-13003140
• Date of registration: 2013-04-10
• Prospective Registration: Yes
• Primary sponsor: Beijing YouAn Hospital, Capital medical university
• Public title: Pharmacokinetic Study of Albuvirtide and Lopinavir/Ritonavir in HIV-infected Patients
• Scientific title: Pharmacokinetic Study of Albuvirtide and Lopinavir/Ritonavir in HIV-infected Patients
• Date of first enrolment: 2013-04-13
• Target sample size: A:10;B:10;
• Recruitment status: Completed
• URL: http://www.chictr.org.cn/showproj.aspx?proj=6419
• Study type: Interventional study
• Study design: Randomized parallel controlled trial
• Phase: I+II (Phase I+Phase II)

Countries of recruitment

China

Contacts

• Name: Hao Wu

• Name: Cheng Yao
• Affiliation: Frontier Biotechnonogies Co.,Ltd

Key inclusion & exclusion criteria

Inclusion criteria: 1. Male or female patients aged 18 to 50 years old;
2. Previously documented HIV infection on standard antibody-based test;
3. HIV RNA >=5000, <1,000,000 copies/ml;
4. CD4+ cell count>=350/ul;
5. In a good healthy condition by physical examination, biochemistry, hematology and urinalysis test, chest X ray examination, B type ultrasonic examination and electrocardiogram etc., without serious liver and renal damages; albumin and other items are in normal range;
6. Naive to antiretroviral therapy or have stopped treatment for at least half a year;
7. Body weight = 40 kg with BMI from 18 to 27 kg/m2;
8. Willingness to abstain from alcohol during the trial;
9. Fully understand the purpose, characteristics, procedures of the trial, as well as the adverse event which might occur during study; Willing and able to sign informed consent.
Exclusion criteria: 1. Patients with acute HIV infection;
2. With severe opportunistic infection or tumors;
3. ALT is 2-fold more than upper limit of normal value, or Creatinine is over upper limit of normal value, or other items are obviously abnormal;
4. With serious chronic disease, metabolic disease (such as diabetes), mental disorder and nervous disease;
5. Had a history of pancreatitis;
6. Had a history of hemophilia A or B;
7. With allergic constitution, or allergic history of the investigational drug and LPV/RTV;
8. Pregnant women, breast feeding women, and women in child-bearing age disagreed with use of birth control;
9. Alcohol abuse or drug abuse;
10. Received any other investigational drugs, HIV fusion inhibitors, or HIV vaccine within 3 months;
11. Received other anti-HIV medicine within half a year before screening;
12. Had a fever with 3 days prior to study entry;
13. Unsuitable to participate in this study in the opinion of the site investigator.

Age minimum: 18
Age maximum: 50
Gender: Both

Health Condition(s) or Problem(s) studied

AIDS

Intervention(s)

A:LPV/RTV and Albuvirtide at a dose of 160mg for 46 days;B:LPV/RTV and Albuvirtide at a dose of 320mg for 46 days;

Primary Outcome(s)

Pharmacokinetics indexe;

Secondary Outcome(s)

Safety indexes;HIV RNA;CD4 count;

Source(s) of Monetary Support

Frontier Biotechnologies Co.,Ltd