Dolutegravir Plus Lamivudine Simplified Therapy

HIV/AIDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03884673
• Other study ID #: V2.0-20181215
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: December 31, 2030

Study information

• Verified date: September 2022
• Source: Guangzhou 8th People's Hospital
• Contact: Linghua Li, PhD
• Phone: 020-83710825
• Email: llheliza[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Intervention

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.

Locations

Country	Name	City	State
China	Guangzhou 8th People's Hospital	Guangzhou	Guangdong

Sponsors (11)

Lead Sponsor

Collaborator

Guangzhou 8th People's Hospital

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

Country where clinical trial is conducted

China, 

References & Publications (3)

Cahn P, Madero JS, Arribas JR, Antinori A, Ortiz R, Clarke AE, Hung CC, Rockstroh JK, Girard PM, Sievers J, Man C, Currie A, Underwood M, Tenorio AR, Pappa K, Wynne B, Fettiplace A, Gartland M, Aboud M, Smith K; GEMINI Study Team. Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 48 results from two multicentre, double-blind, randomised, non-inferiority, phase 3 trials. Lancet. 2019 Jan 12;393(10167):143-155. doi: 10.1016/S0140-6736(18)32462-0. Epub 2018 Nov 9. Erratum in: Lancet. 2018 Nov 28;:. — View Citation

Cahn P, Rolón MJ, Figueroa MI, Gun A, Patterson P, Sued O. Dolutegravir-lamivudine as initial therapy in HIV-1 infected, ARV-naive patients, 48-week results of the PADDLE (Pilot Antiretroviral Design with Dolutegravir LamivudinE) study. J Int AIDS Soc. 2017 May 9;20(1):21678. doi: 10.7448/IAS.20.01.21678. — View Citation

Taiwo BO, Zheng L, Stefanescu A, Nyaku A, Bezins B, Wallis CL, Godfrey C, Sax PE, Acosta E, Haas D, Smith KY, Sha B, Van Dam C, Gulick RM. ACTG A5353: A Pilot Study of Dolutegravir Plus Lamivudine for Initial Treatment of Human Immunodeficiency Virus-1 (HIV-1)-infected Participants With HIV-1 RNA <500000 Copies/mL. Clin Infect Dis. 2018 May 17;66(11):1689-1697. doi: 10.1093/cid/cix1083. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Virus suppression rate	ratio of HIV RNA < 50 copies/mL at 48 and 96 weeks of treatment	96 weeks
Primary	Adverse events	Rate of adverse events reported during the observational period	96 weeks
Secondary	The immunological ability (CD4+)	CD4 cell count (baseline to 48 weeks and 96 weeks)	96 weeks
Secondary	Drug compliance	To explicit the number of people who have completed the treatment	96 weeks
Secondary	The immunological ability (CD8+)	CD4 +/ CD8 + ratio (baseline to 48 weeks and 96 weeks)	96 weeks