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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02211482
• Date of registration: 05/08/2014
• Prospective Registration: Yes
• Primary sponsor: The Huesped Foundation
• Public title: Dolutegravir-Lamivudine as Dual Therapy in Naive HIV-Infected Patients: A Pilot Study PADDLE
• Scientific title: Dolutegravir-Lamivudine as Dual Therapy in Naive HIV-Infected Patients: A Pilot Study
• Date of first enrolment: October 2014
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02211482
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Argentina

Contacts

• Name: Pedro Cahn, PhD
• Affiliation: Fundacion Huesped

Key inclusion & exclusion criteria

Inclusion Criteria:

1. > 18 years of age

2. Documented HIV-1 infection (positive ELISA plus a confirmatory Western Blot; or plasma
HIV-1 RNA =10,000 copies/mL)

3. Voluntarily signed and dated , IRB / IEC approved informed consent form

4. Agrees not to take any other medication during the study

5. Screening HIV RNA >5,000 copies/mL and = 100,000 copies/ml

6. Naïve to ARV therapies

7. CD4 =200 cells/mL

8. Subjects can comply with protocol requirements

9. Subject's general medical condition, in the investigator's opinion, does not interfere
with assessments and completion of the trial

10. Patient is a male or a female not breastfeeding or pregnant

11. A female, may be eligible if she:

1. is of non-child-bearing potential

2. 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)

- IUD and male condom

- Male partner sterilization confirmed and male condom

- Approved hormonal contraception and male condom

- Any other method with published data showing that the expected failure rate
is <1% per year and use male condom

- Any contraception method must be used for at least 2 weeks after
discontinuation of IP

Exclusion Criteria:

1. 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

HIV-1 Infection

Intervention(s)

Drug: dolutegravir, lamivudine

Primary Outcome(s)

Efficacy Outcome Measure [Time Frame: 48 weeks]

Secondary Outcome(s)

safety [Time Frame: 48 week]

Secondary ID(s)

FH-18

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

ViiV Healthcare