Clinical Trials

MainTitle

Dolutegravir Plus Lamivudine Simplified Therapy

This study is currently recruiting participants. (see Contacts and Locations)

Verified June 2019 by Linghua LI, Guangzhou 8th People's Hospital

Sponsor
Guangzhou 8th People's Hospital

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

Information provided by (Responsible Party)
Linghua LI, Guangzhou 8th People's Hospital

ClinicalTrials.gov Identifier
NCT03884673

First received: March 18, 2019
Last updated: June 5, 2019
Last Verified: June 2019
History of Changes
Purpose

Purpose

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.

Condition Intervention
HIV/AIDS

Drug : DTG+ 3TC

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Real World Study: Dolutegravir Plus Lamivudine Simplified Therapy in Treatment Experienced HIV-1 Patients

Further study details as provided by Linghua LI, Guangzhou 8th People's Hospital:

Primary Outcome Measures

  • Virus suppression rate [ Time Frame: 96 weeks ]
    ratio of HIV RNA < 50 copies/mL at 48 and 96 weeks of treatment
  • Adverse events [ Time Frame: 96 weeks ]
    Rate of adverse events reported during the observational period
Secondary Outcome Measures:
  • The immunological ability (CD4+) [ Time Frame: 96 weeks ]
    CD4 cell count (baseline to 48 weeks and 96 weeks)
  • Drug compliance [ Time Frame: 96 weeks ]
    To explicit the number of people who have completed the treatment
  • The immunological ability (CD8+) [ Time Frame: 96 weeks ]
    CD4 +/ CD8 + ratio (baseline to 48 weeks and 96 weeks)

Estimated Enrollment: 300
Study Start Date: January 1, 2019
Estimated Study Completion Date: December 31, 2021
Estimated Primary Completion Date: December 31, 2021 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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 Name: A simplified therapy regimen

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  
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.

Criteria

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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03884673

Contacts

Contact:   Linghua Li, PhD 020-83710825 llheliza@126.com
Contact:   Weiping Cai, Bachelor 020-83710825 gz8hcwp@126.com

Locations

China
Guangzhou 8th People's Hospital Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Linghua Li, PhD    020-83710825    llheliza@126.com

Sponsors and Collaborators

Guangzhou 8th People's Hospital
Shenzhen Third People's Hospital
Dongguan People's Hospital
Fifth Affiliated Hospital, Sun Yat-Sen University
The Third People's Hospital of Guilin
Guangxi Longtan hospital
The Fourth People’s Hospital of Nanning
The Third People's Hospital of Kunming
Yunnan AIDS Care Center
Meng Chao Hepatobiliary Hospital of Fujian Medical University
First Affiliated Hospital of Guangxi Medical University

Investigators

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

More Information


Responsible Party: Linghua LI, Vice Chief physician, Guangzhou 8th People's Hospital  
ClinicalTrials.gov Identifier: NCT03884673   History of Changes  
Other Study ID Numbers: V2.0-20181215  
Study First Received: March 18, 2019  
Last Updated: June 5, 2019  
Individual Participant Data    
Plan to Share IPD: No  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

Keywords provided by Linghua LI, Guangzhou 8th People's Hospital:

DTG + 3TC Simplified Therapy
Simplified Therapy Regimen
Real World Study
HIV-1-infected patients

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections

ClinicalTrials.gov processed this data on August 07, 2020
This information is provided by ClinicalTrials.gov.