Trials Sponsors Conditions Drugs Pricing

Conditions

Acquired Immunodeficiency Syndrome

Outcome Measures

Primary Outcomes (1)

Virologic outcomes
Percentage of participants with virologic failure after 48 weeks of treatment by FDA Snapshot algorithm.
Week 48

Secondary Outcomes (6)

HIV-RNA
Week 24 and Week 48
CD4 counts
Week 24 and Week 48
bone markers
Week 48
DEXA
Week 48
renal markers
Week 24 and Week 48
+1 more secondary outcomes

Study Arms (1)

DTG/3TC

OTHER

Subjects will switch to dolutegravir (DTG) plus lamivudine (3TC) or fixed dose combination DTG/3TC for 48 weeks.

Drug: Dolutegravir 50 MG plus lamivudine 300 MG； Dolutegravir/lamivudine (50 MG/300 MG)

Interventions

Dolutegravir 50 MG plus lamivudine 300 MG； Dolutegravir/lamivudine (50 MG/300 MG)Drug

Subjects will discontinue their TDF + 3TC/FTC-based regimen and will switch to DTG+3TC or fixed dose combination DTG/3TC.

DTG/3TC

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry
Dolutegravir 50 MG plus lamivudine 300 MG； Dolutegravir/lamivudine (50 MG/300 MG)
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Female subjects were required to meet one of the following criteria: 1) Incapacitated, defined as postmenopausal (spontaneous amenorrhea at 12 months, age ≥45 years) or physically unable to conceive after tubal ligation, hysterectomy, or bilateral oophorectomy; 2) Have potential to have children, but are negative at screening and on day 1 pregnancy test, and agree to use appropriate contraceptive methods, including oral contraceptives, condoms and intrauterine devices;

Sponsors & Collaborators

Shanghai Public Health Clinical Center
Governmentlead

Related Publications (1)

Wang Z, Liu L, Chen J, Wang J, Shen Y, Qi T, Tang Y, Song W, Sun J, Xu S, Yang J, Chen Y, Shao Y, Zhang R. Efficacy and Safety of Switching to Dolutegravir/Lamivudine in Virologically Suppressed HIV-1 Infected Adults with TDF-Related Renal or Bone Toxicity. Infect Dis Ther. 2026 Jul;15(7):1913-1924. doi: 10.1007/s40121-026-01363-y. Epub 2026 May 20.
PMID: 42162408DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

dolutegravirLamivudine

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus Diseases

Study Officials

Renfang Zhang
Shanghai Public Health Clinical Center
STUDY CHAIR

Central Study Contacts

Renfang Zhang

CONTACT

+86-18916051096 zhangrenfang@shaphc.org

Study Design

Study Type: interventional
Phase: phase 4
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER GOV
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Clinical professor

Study Record Dates

First Submitted

August 5, 2022

First Posted

August 9, 2022

Study Start

August 2022

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

August 2025

Efficacy and Tolerability of DTG Plus 3TC in HIV Infected Adults With Virologically Suppression and TDF Toxicity

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (1)

DTG/3TC

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (1)

DTG/3TC

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record