HIV Infections Clinical Trial
Official title:
Viral and Immune Dynamics in HIV-Infected Patients With Tuberculosis
The purpose of this study is to see if a type of anti-HIV therapy called HAART is effective
in lowering levels of HIV and boosting the immune system in HIV-infected patients with
tuberculosis (TB).
HIV-infected patients with TB have higher levels of HIV and lower CD4 cell counts (cells in
the body that fight infection) than HIV-infected patients without TB. HAART has been
effective in reducing HIV levels and increasing CD4 cells in patients without TB. However,
its effects in HIV-infected patients with TB are unknown.
Previous studies have focused on characterizing viral and immune dynamics after initiation
of HAART in patients without opportunistic infection. The development of TB in HIV-infected
individuals is associated with an elevation in HIV RNA levels, a decrease in CD4 cell
counts, and an increase in activated (CD38) lymphocytes and proinflammatory cytokines (IL-1,
TNF-alpha, and IL-6). Response to HAART may differ in individuals with an active
opportunistic infection such as TB.
HIV-infected patients with active TB follow an anti-TB regimen including rifabutin and are
observed for a maximum of 24 weeks before they initiate HAART. Plasma samples for 24-hour
post-rifabutin dosing are collected at entry and at Weeks 4, 8, and 12, then again at Weeks
2, 3, 4, 12, and 24 after HAART initiation. Analyses of these samples are used to explore
the relationship between cytokines and rifabutin metabolism and the effect of nelfinavir on
rifabutin pharmacokinetics. The HAART regimen is nelfinavir plus lamivudine (3TC) plus
either zidovudine (ZDV) or stavudine (d4T). After initiation of HAART, all patients undergo
intensive monitoring of viral and immune dynamics for 2 months. The patients continue to be
followed for 1 year from the time of starting HAART. Neither the HAART drug regimen nor
anti-TB medications will be provided by the study and must be obtained by prescription. If
patients are intolerant of the HAART regimen or exhibit virologic rebound, primary providers
can alter or modify this regimen. As part of substudy A5065s, patients who experience signs
or symptoms of paradoxical reactions (i.e., new persistent fevers that develop after
initiating HAART and which last for more than 1 week without an identifiable source; marked
worsening or emergence of intrathoracic lymphadenopathy, pulmonary infiltrates; worsening or
emergence of cervical adenopathy on serial physical examinations; or worsening of other
tuberculous lesions) have additional clinical evaluations (including a chest x-ray, a target
clinical assessment, concomitant medications, and signs and symptoms) weekly for 4 weeks,
then every month thereafter until the symptoms resolve.
;
Endpoint Classification: Efficacy Study, 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 |