HIV Infections Clinical Trial
Official title:
Comparison of Nevirapine Levels With and Without Dose Escalation in HIV-infected Patients Commencing Antiretroviral Therapy Who Are Also Receiving Rifampicin Based Anti-tuberculous Therapy
Verified date | December 2010 |
Source | Makerere University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Uganda: National Council for Science and Technology |
Study type | Interventional |
Triomune is the most commonly prescribed treatment for HIV infection in Uganda. Triomune is
manufactured by a generic drug company and consists of three drugs combined in a single pill
given twice daily (stavudine 30mg plus lamivudine 150mg plus nevirapine 200mg).
It is known that the levels of nevirapine in a patient's blood are highest in the first two
weeks of treatment. Therefore it is recommended that patients starting on nevirapine should
undergo dose escalation i.e start on 200mg once daily for two weeks and then increase to
full dose of 200mg twice daily in order to avoid nevirapine related rash. It is not possible
to do dose escalation with a fixed dose combination pill like Triomune and for the two weeks
of the dose escalation patients either can buy stavudine plus lamivudine plus nevirapine as
separate pills or take Triomune in the morning and then take stavudine plus lamivudine as
separate pills in the evening.
Rifampicin is used to treat TB and lowers the levels of nevirapine in a patient's blood.
This raises two questions in routine clinical practice for patients who are co-infected with
HIV and TB (1) Do we need to put our patients to the trouble of dose escalation of
nevirapine if they are already on rifampicin? and (2) If we dose escalate nevirapine in
patients on rifampicin, are we putting them at risk of low drug levels and development of
resistance? The aim of this study is to compare the plasma concentrations of nevirapine in
HIV infected patients who are commencing antiretroviral therapy with and without a lead in
dose of nevirapine and who are also receiving concomitant treatment with antituberculous
therapy which includes rifampicin to assess whether dose escalation of nevirapine is
appropriate in this patient population
Status | Completed |
Enrollment | 18 |
Est. completion date | December 2010 |
Est. primary completion date | June 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Ability to provide full informed written consent - Confirmed diagnosis of HIV infection - On rifampicin therapy for at least two weeks - Clinical criteria for commencing antiretroviral therapy Exclusion Criteria: - Hemoglobin < 8g/dl - Liver and renal function tests > 3 times the upper limit of normal - Pregnancy - Use of know inhibitors or inducers of Cytochrome P450 or P-glycoprotein. - Use of herbal medications - Intercurrent Illness |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Uganda | Infectious Diseases Institute, Faculty of Medicine, Makerere University | Kampala |
Lead Sponsor | Collaborator |
---|---|
Makerere University | University of Liverpool |
Uganda,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To compare the pharmacokinetics of nevirapine with dose escalation and without dose escalation of nevirapine on day 7, 14 and 21 in patients who are on rifampicin therapy. | 12 months | No | |
Secondary | Safety and tolerability of nevirapine when administered in HIV-TB coinfected patients receiving rifampicin | 1 month | Yes |
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 |