Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-24 @ 10:51 PM
NCT ID:
NCT05493969
Brief Summary:
To investigate the efficacy and tolerability of the regimen of dolutegravir plus lamivudine in HIV infected adults who are virologically suppressed and with evidence of TDF toxicity.
Detailed Description:
This study is a single-center, prospective, uncontrolled, open-label and single-arm interventional study, and aim to investigate the efficacy and safety of dolutegravir plus lamivudine (DTG+3TC) for HIV-infected adults switching from TDF-based triple ART due to TDF toxicity. The study populations are : HIV-infected patients, irrespective of gender, aged 18-75 years old; At least one plasma HIV-1 RNA\<40 c/mL in the 6 months prior to Screening and plasma HIV-1 RNA \<40 c/mL at Screening; Must be on uninterrupted TDF + 3TC / FTC-based regimen for ≥ 6 months prior to Screening; There are clinical manifestations of TDF related adverse reactions. All enrolled subjects will receive DTG + 3TC once daily (DTG + 3TC) for up to 48 weeks. After stable switch indication approved in China mainland, it's allowed for subjects switch from DTG+3TC to fixed dose combination DTG/3TC. The primary endpoint is the percentage of participants with virologic failure at 48 weeks of treatment by FDA Snapshot algorithm. The secondary endpoints are immunologic outcomes and adverse events including bone and renal biomarkers.
Study:
NCT05493969
Study Brief:
Protocol Section:
NCT05493969