HIV Infections Clinical Trial
Official title:
A Multicenter, Open, Randomized, Forty-Eight-Week, Pilot Study to Evaluate the Activity, Safety, and Pharmacokinetics of Indinavir Sulfate, 1200 Mg q 12h and DMP 266, 300 Mg q 12h Versus Indinavir Sulfate, 1000 Mg q 8h and DMP 266, 600 Mg q.h.s.
To estimate the differences in parameters of antiviral activity and safety between a control
regimen of indinavir in combination with DMP 266 and an experimental regimen of higher-dose
indinavir in combination with lower-dose DMP 266 after sixteen weeks of dosing, in protease
inhibitor- and non-nucleoside reverse transcriptase inhibitor-naive, HIV-1 seropositive
patients.
It is hypothesized that after 16 weeks of randomized treatment with either the control or
experimental regimen that:
1. The observed proportion of patients with serum viral RNA < 400 copies/ml in the
experimental and control regimen will be similar and will continue to be so after 48
weeks.
2. The safety profiles of the two groups will be similar, judged by the incidence of
serious, drug-related adverse experiences and the incidence of events of specific
interest (e.g., nephrolithiasis, hyperbilirubinemia, nausea/vomiting, rash, and
CNS-related symptoms) and will continue to be so after 48 weeks.
3. The two groups will be similar with respect to changes from baseline in serum viral RNA
and CD4 counts and will continue to be so after 48 weeks.
It is hypothesized that after 16 weeks of randomized treatment with either the control or
experimental regimen that:
1. The observed proportion of patients with serum viral RNA < 400 copies/ml in the
experimental and control regimen will be similar and will continue to be so after 48
weeks.
2. The safety profiles of the two groups will be similar, judged by the incidence of
serious, drug-related adverse experiences and the incidence of events of specific
interest (e.g., nephrolithiasis, hyperbilirubinemia, nausea/vomiting, rash, and
CNS-related symptoms) and will continue to be so after 48 weeks.
3. The two groups will be similar with respect to changes from baseline in serum viral RNA
and CD4 counts and will continue to be so after 48 weeks.
Patients are randomized to one of two regimens: a control regimen of indinavir plus DMP 266
or an experimental regimen of indinavir plus DMP 266, each at different doses than in the
control regimen.
;
Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, 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 |
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 |