HIV Infections Clinical Trial
Official title:
Efficacy of Thrice Weekly Intermittent Short Course Antituberculosis Chemotherapy in Tuberculosis Patients With and Without HIV Infection
Tuberculosis (TB) is the most common opportunistic infection among HIV infected persons living in developing countries. Directly observed treatment, short-course (DOTS) is the internationally recommended strategy for the treatment of TB. However, the efficacy of DOTS for the treatment of HIV-associated TB is not well studied. This study aims to compare the efficacy of thrice weekly DOTS in HIV-infected versus HIV-negative patients with TB.
Several reports have suggested that the initial response to antituberculosis chemotherapy is
comparable among HIV-positive and negative populations. These series generally demonstrate
that among "surviving" Patients, the bacteriological, clinical, and radiographic responses
are similar between the two groups. However, there are consistent indications of higher
rates of early (first month) deaths from tuberculosis as well as excessive deaths from other
causes during the course of treatment in the above noted series. These deaths appear related
to the advanced stage of tuberculosis at diagnosis as well as the debilitating and
underlying diseased from which the patients suffer and not primarily the drug regimens with
which they are treated. However, several of the reports from Africa suggested increased
early mortality in those who received the less-potent traditional isoniazid, thiacetazone,
and streptomycin regimens than the modern short-course regimens featuring isoniazid,
rifampin, and pyrazinamide. Excess mortality was seen also among a subset of patients with
AIDS and tuberculosis in Uganda receiving a thiacetazone regimen in comparison to those
receiving a rifampin regimen: there was both excess mortality and higher rates of drug
reactions sequestered among those patients who had elevated levels of neopterin and other
markers of cellular immune activation.
Furthermore, several series have shown a modestly greater risk for relapse or recurrence
post treatment for persons with AIDS that seems related to the duration of therapy. Perriens
and colleagues in a study from Zaire compared the outcome of HIV-positive patients treated
with 6-month regimen (2-HRZE daily followed by 10-HR twice weekly) and a 12-month regimen
(2-HRZE daily followed by 10-HR twice weekly). Relapse rates were significantly higher among
those receiving the 6-months regimen (9%) than 12 months of treatment (1.9%) (p < 0.01).
Pulido and colleagues in Spain observed in a non-randomize series that, among patients with
AIDS and tuberculosis, 10 of 40 (24%) patients who received less than 9-months or more did
so. Multivariate analysis identified duration of therapy as a major element in the disparate
relapse rates, with a relative hazard of 9.2 for the shorter-duration therapy. Most
recently, a multicenter national trial in the United States compared 6-month and 9-month of
treatment for HIV-infected adults with pansusceptible tuberculosis. Relapse rates were 3.9%,
two patients, for the 6-month regimen, and 2%, one patient, for the 9-month regimen; because
of the limited number, there was no statistically significant difference.
Several other studies contrasted relapse or cure rates among HIV infected and uninfected
persons treated simultaneously with identical 6-month regimens. They universally showed
somewhat worse outcomes among those with HIV infection.
Hawkens and colleagues described and increased risk of recurrent tuberculosis in a group of
patients from Kenya. This report documented that 10 of 58 (17%) HIV Positive patients
available for follow-up had recurrence, contrasted with 1 of 138 HIV negative patients,
34-fold apparent relative risk. However, 7 of the 10 who experienced recurrence had major
cutaneous drug reactions, interrupting therapy and confounding the issue. But, Elliott in
Zambia noted a marked disparity in relapse rates without the confusing association between
relapses and drug reactions: HIV-positive patients relapsed at a rate 22-100 patient years
of observation versus 6/100 patient years among HIV-negatives. A recent Johns Hopkins study
in Haiti found lower cure rates (69% vs. 79%) and slightly higher relapse rates (5.4% vs.
2.8%, p = 0.36) among HIV-infected individuals receiving a 6-month regimen.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel 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 |