Study of Lopinavir/ Ritonavir and Lamivudine Versus Standard Therapy in Naïve HIV-1 Infected Subjects.

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01237444
• Date of registration: 08/11/2010
• Primary sponsor: Pedro Cahn
• Public title: Study of Lopinavir/ Ritonavir and Lamivudine Versus Standard Therapy in Naïve HIV-1 Infected Subjects. GARDEL
• Scientific title: A Phase 3, Randomized, Open Label, Controlled Study of Lopinavir/Ritonavir and Lamivudine Versus Standard Therapy in Naïve HIV-1 Infected Subjects.
• Date of first enrolment: December 2010
• Target sample size: 417
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01237444
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Argentina

Contacts

• Name: Pedro Cahn, MD, PhD
• Affiliation: FUNDACION HUESPED

Key inclusion & exclusion criteria

Inclusion Criteria:

1. > 18 years of age.

2. Patient with documented HIV-1 infection

3. Subject has voluntarily signed and dated an informed consent form

4. Subject agrees not to take any medication during the study, including over the
counter medicines or herbal preparations, without the approval of the trial
physician.

5. Documented HIV-1 RNA >1,000 copies/mL

6. Subject naïve to ARV. (Patients who had received ARV = 48 hours are allowed).

7. Subject has indication to receive an antiretroviral regimen.

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. If female, :

1. use 2 different methods of birth control including, at least, one barrier
method, and are acceptable to both the subject and investigator, and

2. has a urine pregnancy test performed at the Screening Visit and on Baseline.
Results of both tests must be negative.

3. continue using 2 different methods of birth control including, at least, one
barrier method for at least 30 days after the end of the treatment period

Exclusion Criteria:

- 1. Evidence of viral resistance against lopinavir/ritonavir, and/or FTC or 3TC,
and/or other nucleoside analogues based on the genotype resistance test performed at
screening, considering resistance according to the panel IAS - USA, version in
December, 2009.

2. The presence of any of the following major mutations: V32I; I47V / A; L76V;
V82A/F/T/S or the presence of two or more minor mutations at
positions:10,20,24,33,46,50,53,54,63,71,73,84,90 is considered resistance to
lopinavir/ritonavir.

3. The presence of mutation M184V/I and/or K65R is considered resistance to 3TC or
FTC. At the discretion of the investigator and based on the resistance test, a
treatment based on lopinavir / ritonavir, plus 3TC or FTC and other similar
nucleoside / nucleotide active could not be constructed.

4. Previously documented HIV-2 infection. 5. Use of disallowed concomitant therapy 6.
Patient has a current (active) diagnosis of acute hepatitis due to any cause OR
chronic Hepatitis C WITH aspartate aminotransferase (AST) and/or alanine
aminotransferase (ALT) >5 x upper limit of normal (ULN) AND/OR is likely to require
treatment in the next year.

7. Active Hepatitis B infection (regardless of stage of infection). 8. Any active
clinically significant disease . 9. Subject has a currently active AIDS defining
illness (Category C)30 days of screening. Subjects who are on stable maintenance
therapy for an opportunistic infection may be enrolled.

10. Life expectancy < 1 year according to the judgment of the investigator. 11.
Screening laboratory analysis shows any of the following abnormal laboratory results:

a. Hemoglobin < 8.0 g/dL b. Absolute neutrophil count < 750 cells/µL c. Platelet
count < 50,000 mm3 d. Creatinine> 1.5 times the normal upper limit. 12. Subject
enrolled in other clinical trials . 13. Use of any investigational agents within 30
days prior to screening. 14. Use of immunosuppressive drugs, cytokine inhibitors or
other cytokines in the last year.

15. Active substance use or abuse that the investigator determines may significantly
interfere with study procedures 16. Any condition (including but not limited to
alcohol and drug use) which in the opinion of the investigator, could compromise the
subject's safety or adherence to the protocol.

17. Subject is pregnant or breast-feeding.



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

Health Condition(s) or Problem(s) studied

HIV Infection

Intervention(s)

Drug: lopinavir /ritonavir plus two nucleosides

Drug: lopinavir/ritonavir plus one nucleoside

Primary Outcome(s)

• Proportion of patients with HIV-1 RNA levels of less than 50 copies/mL in an intent-to-treat analysis at week 48 [Time Frame: 48 and 96 weeks]

Secondary Outcome(s)

• Proportion of patients with HIV-1 RNA levels of less than 400 copies/mL at week 24 and at week 48 [Time Frame: 48 weeks]

Secondary ID(s)

FH-10 GARDEL study

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Abbott