HIV Infections Clinical Trial
Official title:
Evaluation of the Pharmacokinetics and Tolerability of Increased Dosage of Lopinavir/Ritonavir(LPV/r) in Individuals Experiencing Viremia on Standard Dose LPV/r Using LPV/r Tablet Formulation
This study will look to see if increasing the standard dose of Kaletra is tolerated and if it will lower viral loads to undetectable levels. This study will also look at the pharmacokinetic data (amount of Kaletra in blood at different times).
There are several reasons for low level viremia in patients on Kaletra (LPV/r), including
poor adherence, incomplete absorption, cellular drug pumps or resistance mutations.
Increasing exposure to protease inhibitors via boosting with ritonavir increases minimum
blood concentrations, and is a strategy which has been shown to improve suppression of
virologic replication. Little is known about the pharmacokinetics (PK), tolerability and
safety of increased doses of LPV/r. The objectives of this 24-week single arm pilot study
are to assess the PK parameters, safety, tolerability, change in viral load and CD4 counts
on increased dose (600/150 and 800/200 mg) LPV/r in participants with low level viremia on
standard dose LPV/r-based ART. Participants will undergo six PK samplings over 12 hours on
standard dose LPV/r. The dose will be increased to 3 tabs (600/150) BID and blood will be
sampled for PK after two weeks. If tolerated at 8 weeks, the dose will be increased to 4
tabs (800/200 mg) BID and final PK sampling will be performed after two weeks. There will be
a one time, optional, optimization of background regimen of NRTIs two weeks after the first
dose escalation.
Major Eligibility Criteria:
- CD4 count: > 50
- Viral load: 200-75,000 on two most recent measures
- Current treatment: > 16 weeks standard dose (400/100mg BID) LPV/r-based ART (no other
PI or NNRTI allowed
- Prior treatment experience and resistance profile: Up to 20-fold resistance to LPV/r
;
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| 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 |
NCT03141918 -
Effect of Supplementation of Bioactive Compounds on the Energy Metabolism of People Living With HIV / AIDS
|
N/A | |
| 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 | |
| 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 |