Study of Lopinavir/ Ritonavir and Lamivudine Versus Standard Therapy in Naïve HIV-1 Infected Subjects. (GARDEL)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01237444 |
Recruitment Status :
Completed
First Posted : November 9, 2010
Last Update Posted : June 12, 2012
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infection | Drug: lopinavir/ritonavir plus one nucleoside Drug: lopinavir /ritonavir plus two nucleosides | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 417 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 3, Randomized, Open Label, Controlled Study of Lopinavir/Ritonavir and Lamivudine Versus Standard Therapy in Naïve HIV-1 Infected Subjects. |
Study Start Date : | December 2010 |
Actual Primary Completion Date : | May 2012 |
Actual Study Completion Date : | May 2012 |
Arm | Intervention/treatment |
---|---|
Experimental: lopinavir/ritonavir plus lamivudine
ARM 1: Lopinavir/ritonavir 200mg/50mg 2 tabs bid plus 3TC 150mg x1 tab bid |
Drug: lopinavir/ritonavir plus one nucleoside
ARM 1: Lopinavir/ritonavir 200mg/50mg 2 tabs bid plus 3TC 150mg x1 tab bid |
Active Comparator: lopinavir/ritonavir plus two nucleosides
ARM 2: 3TC 150mg x1 tab bid or FTC 200mg 1 capsule qd plus Lopinavir/ritonavir 200mg/50mg 2 tabs BID plus a second NRTI, selected at investigator's discretion, based on baseline genotype |
Drug: lopinavir /ritonavir plus two nucleosides
ARM 2: 3TC 150mg x1 tab bid or FTC 200mg 1 capsule qd plus Lopinavir/ritonavir 200mg/50mg 2 tabs BID plus a second NRTI, selected at investigator's discretion, based on baseline genotype. |
- • 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 ]
- • 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 ]
- Proportion of patients with HIV-1 RNA levels of less than 50 copies/mL at week 24.
- Number and type of resistance mutations in case of virologic failure• CD4+ lymphocyte count and proportion evolution between baseline and week 24 and 48.
- Comparison of lipid profiles after 48 weeks
- Changes in quality of life, assessed by a validated questionnaire
- Treatment survival and interruptions.
- Frequency, type and severity of adverse events.
- Frequency of opportunistic infections (OI) and disease progression.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- > 18 years of age.
- Patient with documented HIV-1 infection
- Subject has voluntarily signed and dated an informed consent form
- 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.
- Documented HIV-1 RNA >1,000 copies/mL
- Subject naïve to ARV. (Patients who had received ARV ≤ 48 hours are allowed).
- Subject has indication to receive an antiretroviral regimen.
- 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.
-
If female, :
- use 2 different methods of birth control including, at least, one barrier method, and are acceptable to both the subject and investigator, and
- has a urine pregnancy test performed at the Screening Visit and on Baseline. Results of both tests must be negative.
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01237444
Argentina | |
Fundacion Huesped | |
Ciudad de Buenos Aires, Argentina, C1202ABB |
Principal Investigator: | Pedro Cahn, MD, PhD | FUNDACION HUESPED |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Pedro Cahn, MD, Fundación Huésped |
ClinicalTrials.gov Identifier: | NCT01237444 |
Other Study ID Numbers: |
FH-10 GARDEL study |
First Posted: | November 9, 2010 Key Record Dates |
Last Update Posted: | June 12, 2012 |
Last Verified: | June 2012 |
Lopinavir/ritonavir plus 3TC as a dual therapy regimen. |
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Lopinavir |
HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors |