Study on the efficacy and safety of Dolutegravir combined with Lamivudine in the treatment of HIV infections

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2300072308

Enrollment

Unknown

Registered

2023-06-09

Start date

2020-08-01

Completion date

Unknown

Last updated

2023-06-18

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

Conditions

Acquired immune deficiency syndrome

Interventions

Observational group (Antiretroviral treatment using dotilavena and lamivide (DTG+3TC) drugs):None

Control group (Antiviral therapy with three-drug solutions of efiveren, lamivodine and tinofovir fumarate (EFV+3TC+TDF)):None

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Criteria for selection: (a) 18-65 years old; (b) gender is not limited; (c) ELISA tested positive for HIV-1 antibodies and confirmed by the Western Blot method; (d) voluntarily signed the patient's informed consent form and was able to be followed up; (e) there was no plan to move away from the current test site during the trial; (f) the subjects had not received any antiretroviral treatment before that; and (g) women who gave birth were required to use efficient contraception.

Exclusion criteria

Exclusion criteria: Criteria for exclusion: (a) patients with HBs-Ag (+) and/or HBV-DNA positive; (b) opportunistic infection occurred within 2 weeks before selection; (c) chronic kidney disease (blood creatinine levels exceeding the upper limit of more than twice the normal value), creatinine clearance (CCr) < 60 mL/min, liver diseases (transaminase and alkaline phosphatase exceed the upper limit, and bilirubin levels more than 2.5 times the upper limit); (d) known history of osteoporosis, osteoporosis fractures or other metabolic/hereditary osteopathy, osteoporosis treatment; (e) rheumatoid arthritis; (f) have taken vitamin D3 supplements and calcium supplements and refused to stop at the group; (g

Design outcomes

Primary

Measure	Time frame
HIV virus load;CD4+T lymphocyte count;CD4+/CD8+;	—

Secondary

Measure	Time frame
Blood routine;Liver function;Kidney function;Blood lipids;Urine routine;	—

Countries

China

Contacts

Public ContactDou Yanyun

Chest Hospital of Guangxi Zhuang Autonomous Region (Longtan Hospital of Guangxi Zhuang Autonomous Region)

liao5657@163.com+86 137 6842 9854

Outcome results

None listed

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