Dolutegravir-Lamivudine as Dual Therapy in Naive HIV-Infected Patients: A Pilot Study

NCT02211482 | Completed Phase 4

• 1 other identifier: FH-18
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the antiviral efficacy, safety and tolerability of dual therapy with 3TC and DTG as initial therapy among naïve HIV patients

Conditions

HIV-1 Infection

Keywords

HIV-1 infected patients; dual therapy

Outcome Measures

Primary Outcomes (1)

• Efficacy Outcome Measure

  Percentage of Participants with HIV-1 RNA levels of less than 50 copies/mL at week 48 by ITT analysis

  48 weeks

Secondary Outcomes (1)

• safety

  48 week

Other Outcomes (5)

• efficacy

  24 weeks

• safety

  48 weeks

• efficacy

  12 weeks

Study Arms (1)

Dolutegravir , lamivudine

OTHER

Dolutegravir 50 mg QD plus lamivudine 300 mg QD

Drug: dolutegravir, lamivudine

Interventions

dolutegravir, lamivudine DRUG

single arm

Also known as: dolutegravir, lamivudine

Dolutegravir , lamivudine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 18 years of age
• Documented HIV-1 infection (positive ELISA plus a confirmatory Western Blot; or plasma HIV-1 RNA ≥10,000 copies/mL)
• Voluntarily signed and dated , IRB / IEC approved informed consent form
• Agrees not to take any other medication during the study
• Screening HIV RNA \>5,000 copies/mL and ≤ 100,000 copies/ml
• Naïve to ARV therapies
• CD4 ≥200 cells/mL
• Subjects can comply with protocol requirements
• Subject's general medical condition, in the investigator's opinion, does not interfere with assessments and completion of the trial
• Patient is a male or a female not breastfeeding or pregnant
• A female, may be eligible if she:
• is of non-child-bearing potential
• is of child-bearing potential with a negative pregnancy test at Screening and Day 1 and agrees to use one of the following methods:
• Complete abstinence from penile-vaginal intercourse from 2 weeks prior to administration of IP, throughout the study, and for at least 2 weeks after
• Double barrier method (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide)

You may not qualify if:

• \. Genotypic resistance to lamivudine at screening,as per IAS -USA Panel 2013 2. Alcohol or drug use that might impact on adherence 3. Subjects positive for Hepatitis B at screening (+HBsAg), or anticipated need for Hepatitis C virus (HCV) therapy during the study 4. Lactating, pregnancy or fertile women willing to be pregnant 5. Concomitant use of lowering lipid drugs, interferon, interleukin-2, cytotoxic chemotherapy, Dofetilide (or pilsicainide ) or immunosuppressors at study entry 6. Grade 4 lab abnormalities 7. Primary HIV infection (indeterminate WB or previous negative HIV in the last 6 months.) 8. Opportunistic infection (CDC C category) or other disease and/or clinical condition that, in the investigator's opinion, would compromise the patient's safety or outcome of the study; including malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia 9. Subjects who in the investigator's judgment, poses a significant suicidality risk 10. History or presence of allergy to the study drugs or their components or drugs of their class 11. Treatment with any of the following agents within 28 days of Screening: radiation therapy; cytotoxic chemotherapeutic agents; any immunomodulators that alter immune responses or treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening or exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of investigational product 12. Any acute laboratory abnormality at Screening, which, in the opinion of the Investigator, would preclude the subject's participation in the study of an investigational compound 13. Alanine aminotransferase (ALT) \>5 times the upper limit of normal (ULN), or ALT ≥ 3xULN and bilirubin ≥ 1.5xULN (with \>35% direct bilirubin) 14. Creatinine clearance of \<50 mL/min via Cockcroft-Gault method 15. Subjects with moderate to severe hepatic impairment (Class B or greater) as determined by Child-Pugh classification

Sponsors & Collaborators

• Fundación Huésped: lead
• ViiV Healthcare: collaborator

Study Sites (1)

Fundacion Huesped

CABA, Buenos Aires, C1202ABB, Argentina

Location

Related Publications (1)

• Cahn P, Rolon 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.

  PMID: 28537061 DERIVED

MeSH Terms

Interventions

dolutegravir; Lamivudine

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides

Study Officials

• Pedro Cahn, PhD

  Fundacion Huesped

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: August 5, 2014
• First Posted: August 7, 2014
• Study Start: October 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: April 1, 2017
• Last Updated: August 14, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will share

Locations

AR (1)