Preliminary Evaluation of the Safety and Efficacy of the Antiretroviral Regimen of 2 NRTIs Drugs Combined with Albuvirtide in the Treatment of HIV/AIDS Patients with Tuberculosis Infection

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2200062461

Enrollment

Unknown

Registered

2022-08-08

Start date

2022-08-01

Completion date

Unknown

Last updated

2023-04-12

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

Conditions

HIV-1

Interventions

Albuvirtide Therapy Group:2 NRTIS combined with Albuvirtide

Efavirenz Therapy Groups:2 NRTIS combined with Efavirenz (EFV)

Eligibility

Sex/Gender

All

Age

16 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Chinese subjects aged 16-65 years (including the critical value), male or female; 2. HIV-1 naive patients who have not received ART treatment; 3. Biological test or clinical diagnosis of active Pulmonary Tuberculosis, need to receive anti-tuberculosis treatment with the rifampicin-containing regimen for at least 24 weeks and start anti-tuberculosis treatment within 4 weeks; 4. Baseline HIV-1 viral load: 10^6 copies/mL > Plasma HIV1-RNA > 1000 copies/mL; 5. Voluntarily sign the patient's informed consent.

Exclusion criteria

Exclusion criteria: 1. Those who are known to be resistant to NRTIs; 2. The following results were detected during the screening period: hemoglobin 1.5 times the upper limit of normal, aspartate aminotransferase/alanine aminotransferase/alkaline phosphatase >3 times the upper limit of normal, and total bilirubin >2 times the upper limit of normal; 3. Patients with chronic obstructive pulmonary disease or acute and chronic asthma; 4. Pregnant and lactating women; 5. Those who have family planning; 6. Current drug addicts; 7. Patients with serious mental and neurological diseases; 8. Those who have a history of alcoholism and cannot be terminated; 9. Severe peptic ulcer; 10. Patients with acute and chronic hepatitis B or C, acute and chronic pancreatitis; 11. Other researchers think that it is not suitable to participate in this study.

Design outcomes

Primary

Measure	Time frame
Plasma HIV1-RNA;	—

Secondary

Measure	Time frame
CD4+ T lymphocytes;Etiological examination;Pulmonary imaging;Drug resistance detection;	—

Countries

China

Contacts

Public ContactHongzhou Lu

The Second Affiliated Hospital of Southern University of Science and Technology (The Third People's Hospital of Shenzhen)

yangzhou@szsy.sustech.edu.cn+86 13925236605

Outcome results

None listed

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