Dolutegravir Plus Lamivudine Dual Therapy in Treatment Naïve HIV-1 Patients

Recruiting in Palo Alto (17 mi)

+25 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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. DTG is a type of HIV medicine called an integrase inhibitor; 3TC is a type of HIV medicine called a reverse transcriptase inhibitor. DTG works by blocking integrase and 3TC works by blocking reverse transcriptase, two HIV proteins (enzymes). This prevents HIV from multiplying and lowers the viral load (amount of HIV in the blood). Both DTG and 3TC are currently part of Food and Drug Administration (FDA) recommended regimens along with a third active drug. Since some HIV medicines have side effects and are costly, there is interest in whether HIV can be successfully controlled with fewer than three HIV drugs.

Research Team

Babafemi Taiwo, MBBS

Principal Investigator

Northwestern University

Roy Gulick, MD, MPH

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

Inclusion Criteria

NOTE: Further information on the eligibility criteria can be found in the study protocol.

HIV-1 infection.

Plasma HIV-1 RNA ≥1000 copies/mL and <500,000 copies/mL obtained within 90 days prior to study entry.

Treatment Details

Interventions

• Dolutegravir (Integrase Inhibitor)
• Lamivudine (Reverse Transcriptase Inhibitor)

Participant Groups

Group I: Arm 1: DTG 50 mg + 3TC 300 mg Experimental Treatment 2 Interventions

Dolutegravir 50mg and Lamivudine 300mg, orally daily

Dolutegravir is already approved in European Union, United States, Canada, Japan, Switzerland for the following indications:

🇪🇺 Approved in European Union as Tivicay for:

• HIV-1 infection

🇺🇸 Approved in United States as Tivicay for:

• HIV-1 infection

🇨🇦 Approved in Canada as Tivicay for:

• HIV-1 infection

🇯🇵 Approved in Japan as Tivicay for:

• HIV-1 infection

🇨🇭 Approved in Switzerland as Tivicay for:

• HIV-1 infection

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

The Ponce de Leon Center CRS (5802) Atlanta, GA

Northwestern University CRS (2701) Chicago, IL

Massachusetts General Hospital ACTG CRS (101) Boston, MA

Brigham and Women's Hosp. ACTG CRS (107) Boston, MA

More Trial Locations

Who Is Running the Clinical Trial?

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Lead Sponsor

Trials

103

Patients Recruited

74,200+

AIDS Clinical Trials Group

Lead Sponsor

Trials

101

Patients Recruited

73,600+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3361

Patients Recruited

5,516,000+