Dolutegravir Plus Lamivudine Simplified Therapy

September 13, 2022 updated by: Linghua LI, Guangzhou 8th People's Hospital

Real World Study: Dolutegravir Plus Lamivudine Simplified Therapy in Treatment Experienced HIV-1 Patients

Dolutegravir (DTG) is one type of integrase inhibitor, lamivudine (3TC) is one type of reverse transcriptase inhibitor, both of which are HIV medicine prevents HIV from self-multiplying, reduces the viral load. The data of the existing randomized controlled clinical studies show that the simplified two-drug DTG-based regimen is similar to the three-drug regimen in terms of efficacy, but there are no relevant data and reports on the efficacy and safety of DTG+3TC in HIV-infected patients in China so far. This project aims to explore the efficacy and safety of the DTG + 3TC regimen for HIV-infected patients in real clinical environment, to guide clinical application, and to provide a theoretical basis for the selection of simplified schemes for the formulation of guidelines.

This study was done to see if the combination of two anti-HIV medicines, dolutegravir (DTG, Tivicay) and lamivudine (3TC, Epivir) taken once a day, provide a safe, effective, and well-tolerated treatment for HIV.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is an open-label, multicentered, single-arm and phase IV clinical trial. 300 HIV-infected patients who received simplified treatment regimen (50mg DTG+ 400mg 3TC, oral, qd) were selected to observe the treatment efficacy. At week 24, 36, 48 and 96, the rate of viral suppression and CD4 cell count were calculated against baseline. In addition, the safety and drug compliance were also monitored.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Weiping Cai, Bachelor
  • Phone Number: 020-83710825
  • Email: gz8hcwp@126.com

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Guangzhou 8th People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who are prescribed to take the simplified therapy regimen (DTG+ 3TC) because they are unable to tolerate the side-effect of or are not fit for the first-line free regimen in China, for example renal failure or osteoporosis, according to clinical judgment, no matter of the HIV-RNA viral loads and CD4 cell counts.

Description

Inclusion Criteria:

  1. Age (> 18 years), male and female;
  2. HIV-1 infected;
  3. Using a standard three-drug-based regimen for at least 24 weeks. Based on clinical decision making* decide if patients can be treated with the DTG+3TC simplified scheme for a variety of reasons, such as (but not limited to): patients cannot tolerate the conventional three-drug treatment scheme, renal insufficiency, osteoporosis, bone marrow suppression and for other reasons patients cannot use the conventional three-drug treatment scheme;
  4. Initial HIV-1 RNA viral load and CD4 cell count were unlimited.
  5. CD4 can be monitored at least three times in the first year (including baseline, 24 weeks of treatment and 48 weeks of treatment). After the first year, CD4 can be detected at least once every six months.
  6. State Informed Consent for Free Treatment has been signed;
  7. Good compliance and signing Informed Consent

(* Reference criteria: Refer to APSIRE study, creatinine clearance rate (> 50 mL/min), no DTG/3TC allergy history, HBsAg negative, no chronic liver disease, no severe liver damage, no pregnancy during the study)

Exclusion Criteria:

  1. Has participated in other clinical trials of HIV vaccine or other drug trials in the past three months;
  2. Researchers decide if patients could/not complete the scheduled follow-up (factors to consider such as weak, poor compliance, etc.).
  3. Has a clear history of DTG or 3TC allergy;
  4. HBsAg and/or HBV-DNA positive;
  5. Pregnancy during the study period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
DTG+3TC
These cases were given simplified therapy regimen including DTG (50 mg, oral,qd) combined with 3TC (300 mg,oral,qd).
Drug: DTG+ 3TC
It is a simplified therapy regimen study of dolutegravir combined with lamivudine for HIV-1 infected patients in the real world of China.
Other Names:
  • A simplified therapy regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Virus suppression rate
Time Frame: 96 weeks
ratio of HIV RNA < 50 copies/mL at 48 and 96 weeks of treatment
96 weeks
Adverse events
Time Frame: 96 weeks
Rate of adverse events reported during the observational period
96 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The immunological ability (CD4+)
Time Frame: 96 weeks
CD4 cell count (baseline to 48 weeks and 96 weeks)
96 weeks
Drug compliance
Time Frame: 96 weeks
To explicit the number of people who have completed the treatment
96 weeks
The immunological ability (CD8+)
Time Frame: 96 weeks
CD4 +/ CD8 + ratio (baseline to 48 weeks and 96 weeks)
96 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou 8th People's Hospital

Collaborators

Fifth Affiliated Hospital, Sun Yat-Sen University
Dongguan People's Hospital
First Affiliated Hospital of Guangxi Medical University
Meng Chao Hepatobiliary Hospital of Fujian Medical University
Shenzhen Third People's Hospital
Yunnan AIDS Care Center
The Third People's Hospital of Guilin
Guangxi Longtan hospital
The Fourth People's Hospital of Nanning
The Third People's Hospital of Kunming

Investigators

  • Principal Investigator: Weiping Cai, Bachelor, Guangzhou 8th People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

December 31, 2030

Study Registration Dates

First Submitted

March 18, 2019

First Submitted That Met QC Criteria

March 20, 2019

First Posted (Actual)

March 21, 2019

Study Record Updates

Last Update Posted (Actual)

September 14, 2022

Last Update Submitted That Met QC Criteria

September 13, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V2.0-20181215

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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