Clinical Trials Logo
  1. Home
  2. HIV Infections
  3. NCT01159223
  4. Details
NCT01159223 Clinical Trial

Low Dose Atazanavir/r Versus Standard Dose Atazanavir/r (LASA)

HIV Infections Clinical Trial

Official title:
A Multicenter Randomized Study to Compare the Efficacy and Safety of Lower Dose Atazanavir /Ritonavir (ATV/r 200/100 OD) Versus Standard Dose (ATV/r 300/100 mg OD) in Combination With 2NRTIs in Well Virology Suppressed HIV-infected Adults

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01159223
Other study ID # HIV - NAT 110
Secondary ID
Status Completed
Phase Phase 4
First received June 4, 2010
Last updated August 17, 2016
Start date May 2011
Est. completion date June 2015

Study information
Verified date August 2016
Source The HIV Netherlands Australia Thailand Research Collaboration
Contact n/a
Is FDA regulated No
Health authority Thailand: Ethical Committee
Study type Interventional

Clinical Trial Summary

This study will compare the efficacy and safety of ATV/r at either 200/100 mg or 300/100mg given daily in Thai patients in combination with 2NRTIs.

Description:

To demonstrate non-inferiority of treatment with atazanavir/ritonavir (ATV/r) 200/100 mg once daily (OD) compared to the control group (ATV/r 300/100 mg OD) in regards to the proportion of virologic responders (plasma HIV RNA < 200 copies/mL) at 48 weeks in ARV-experienced HIV-1 infected subjects.

Recruitment information / eligibility
Status Completed
Enrollment 559
Est. completion date June 2015
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. HIV infected adults aged more than or equal to 18 years

2. Received ritonavir boosted PI-based HAART for >3 months prior screening visit

3. History of HIV RNA < 50 copies/ml within 12 months prior to screening visit

4. HIV-RNA < 50 copies/ml at screening visit

5. Signed written informed consent

Exclusion Criteria:

1. Active AIDS-defining disease or active opportunistic infection

2. History of virological failure (plasma HIV-RNA =1,000 copies/ml) while using any ritonavir boosted PI-based HAART

3. Pregnancy or lactation at screening visit

4. Relevant history or current conditions or illnesses that might interfere with drug absorption, distribution, metabolism or excretion e.g. chronic diarrhea, malabsorption

5. Use of concomitant medication that may interfere with the pharmacokinetics of the study drugs e.g. rifampicin, proton pump inhibitor

6. History of sensitivity/idiosyncrasy to the drug or chemically related compounds which may be employed in the study

7. ALT =200 IU/L at screening visit

8. Creatinine clearance < 60 c.c. per min by Cockroft-Gault formula at screening visit

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• ATV/r
All participants will be randomized to take ATV/r 200 mg/100 mg OD or ATV/r 300/100 mg OD. NRTIs background regimens will remain unchanged if possible. NRTIs background may include zidovudine/lamivudine, zidovudine plus ddI, ddI plus lamivudine, tenofovir plus lamivudine, tenofovir/emtricitabine, zidovudine plus tenofovir. NRTI backbone could be switched or modified due to toxicity or intolerance

Locations
Country Name City State
Thailand BMA Medical College and Vajira Hospital Bangkok
Thailand HIV-NAT, Thai Red Cross AIDS Research Centre Bangkok
Thailand Ramathibodi Hospital Bangkok
Thailand Taksin hospital Bangkok
Thailand Chiang Rai Regional Hospital Chiang Rai
Thailand ChonBuri Hospital ChonBuri
Thailand Khon Kaen Hospital Khon Kaen
Thailand Khon Kaen University Khon Kaen
Thailand Bamrasnaradura Infectious Diseases Institute Nonthaburi
Thailand Sanpathong Hospital Sanpathong Chiang Mai

Sponsors (3)
Lead Sponsor Collaborator
The HIV Netherlands Australia Thailand Research Collaboration Kirby Institute, National Health Security Office, Thailand

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

Bunupuradah T, Kiertiburanakul S, Avihingsanon A, Chetchotisakd P, Techapornroong M, Leerattanapetch N, Kantipong P, Bowonwatanuwong C, Banchongkit S, Klinbuayaem V, Mekviwattanawong S, Nimitvilai S, Jirajariyavej S, Prasithsirikul W, Munsakul W, Bhakeech — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary noninferiority ATV/r 200/100 mg will be judged to be non-inferior to ATV 300/100mg if the lower limit of the 95% confidence interval for the difference in proportion of patients with virological response between the two groups does not exceed -10% Dec. 2013 Yes
Secondary viral load A secondary efficacy analysis will explore the impact of changing the lower limit of detection of viral load to <50 copies/mL DEc. 2013 Yes
Secondary serious adverse events Changes in HDL, LDL, cholesterol, triglycerides and bilirubin, or having grade 3 and 4 laboratory adverse events Dec. 2013 Yes
See also
  Status Clinical Trial Phase
Completed NCT05454514 - Automated Medication Platform With Video Observation and Facial Recognition to Improve Adherence to Antiretroviral Therapy in Patients With HIV/AIDS N/A
Completed NCT03760458 - The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age Phase 1/Phase 2
Completed NCT03067285 - A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study Phase 4
Completed NCT03141918 - Effect of Supplementation of Bioactive Compounds on the Energy Metabolism of People Living With HIV / AIDS N/A
Recruiting NCT04579146 - Coronary Artery Disease (CAD) in Patients HIV-infected
Completed NCT06212531 - Papuan Indigenous Model of Male Circumcision N/A
Active, not recruiting NCT03256422 - Antiretroviral Treatment Taken 4 Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients Phase 3
Completed NCT03256435 - Retention in PrEP Care for African American MSM in Mississippi N/A
Completed NCT00517803 - Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies N/A
Active, not recruiting NCT03572335 - Systems Biology of Diffusion Impairment in Human Immunodeficiency Virus (HIV)
Completed NCT04165200 - Fecal Microbiota Transplantation as a Therapeutic Strategy for Patients Infected With HIV N/A
Recruiting NCT03854630 - Hepatitis B Virus Vaccination in HIV-positive Patients and Individuals at High Risk for HIV Infection Phase 4
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A
Completed NCT02234882 - Study on Pharmacokinetics Phase 1
Completed NCT01618305 - Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission Phase 4
Recruiting NCT05043129 - Safety and Immune Response of COVID-19 Vaccination in Patients With HIV Infection
Not yet recruiting NCT05536466 - The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine N/A
Recruiting NCT04985760 - Evaluation of Trimer 4571 Therapeutic Vaccination in Adults Living With HIV on Suppressive Antiretroviral Therapy Phase 1
Completed NCT05916989 - Stimulant Use and Methylation in HIV
Terminated NCT02116660 - Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284) Phase 2

External Links