Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dolutegravir Plus Lamivudine Simplified Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03884673
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : June 6, 2019
Sponsor:
Collaborators:
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

Brief Summary:

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 or disease Intervention/treatment
HIV/AIDS Drug: DTG+ 3TC

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Real World Study: Dolutegravir Plus Lamivudine Simplified Therapy in Treatment Experienced HIV-1 Patients
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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 Name: A simplified therapy regimen




Primary Outcome Measures :
  1. Virus suppression rate [ Time Frame: 96 weeks ]
    ratio of HIV RNA < 50 copies/mL at 48 and 96 weeks of treatment

  2. Adverse events [ Time Frame: 96 weeks ]
    Rate of adverse events reported during the observational period


Secondary Outcome Measures :
  1. The immunological ability (CD4+) [ Time Frame: 96 weeks ]
    CD4 cell count (baseline to 48 weeks and 96 weeks)

  2. Drug compliance [ Time Frame: 96 weeks ]
    To explicit the number of people who have completed the treatment

  3. The immunological ability (CD8+) [ Time Frame: 96 weeks ]
    CD4 +/ CD8 + ratio (baseline to 48 weeks and 96 weeks)



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884673


Contacts
Layout table for location contacts
Contact: Linghua Li, PhD 020-83710825 llheliza@126.com
Contact: Weiping Cai, Bachelor 020-83710825 gz8hcwp@126.com

Locations
Layout table for location information
China, Guangdong
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
Layout table for investigator information
Principal Investigator: Weiping Cai, Bachelor Guangzhou 8th People's Hospital
Publications:
Layout table for additonal information
Responsible Party: Linghua LI, Vice Chief physician, Guangzhou 8th People's Hospital
ClinicalTrials.gov Identifier: NCT03884673    
Other Study ID Numbers: V2.0-20181215
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases