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

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

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-11001548
Enrollment
Unknown
Registered
2011-08-29
Start date
2008-05-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AIDS

Interventions

80mg Group:Placebo:2, 80mg Albuvirtide: 6
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

Sponsors

Beijing You’an Hospital affiliated to Capital medical university
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria: 1. Patients with acute HIV infection; 2. ALT< twice of upper limit or Creatinine is abnormally high or other biochemical test results are abnormal; 3. Patients who received anti-HIV medicine within half year before screening; 4. Patients with severe opportunistic infection or tumors; 5. Patient is allergic constitution or allergic to more than two drugs or food; 6. Patients with severe digestive, hematological, metabolic, neurological, mental disorder, or any inherited disease; 7. Pregnant or lactating women or women who won't take contraceptive intervention during the trial; 8. Patients with fever within 3 days; 9. Patients with other issues that is not eligible to this trial.

Design outcomes

Primary

MeasureTime frame
Lab test (hematology, biochemistry, CD4+ cell count, virus loads, urine analysis);

Countries

China

Contacts

Public ContactHao Wu
wuhdoc@public.bta.net.cn+86 010 63053963

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026