HIV Infections Clinical Trial
Official title:
EVALUATION OF THE EFFECT OF ARTEMISIA ANNUA AND MORINGA OLEIFERA ON IMMUNOLOGICAL RESPONSE IN HAART HIV PATIENTS at MRRH
Verified date | February 2020 |
Source | Mbarara University of Science and Technology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Introduction Artemisia annua L is a medicinal plant traditionally used for treatment of malaria and other diseases in China. The extract of leaves of the plant has been demonstrated in-vitro to have potent anti HIV effects and in vivo to improve levels of lymphocytes in laboratory animals. Effect on lymphocyte stimulation has also been observed in non HIV persons taking the leaves of the plant as a tea for malaria prophylaxis in Uganda. Objective To determine the effect of A.annua L and Moringa oleifera leaf powder on CD4 cell count and other immunological indices in HAART HIV patients. Materials and Methods In this study Artemisia annua leaf powder and Moringa leaf powder will be investigated. The study will be a three arm randomized Phase II study involving adult patients with HIV-infection on HAART with CD4 below 350. The CD4 cell count, and other immunological indices in patients receiving HAART will be compared with those patients receiving additionally Artemisia annua powder with Moringa oleifera powder or Artemisia annua powder alone. The study will be conducted at the HIV clinic in Mbarara Regional Referral Hospital while laboratory tests will be done at Mbarara University of Science and Technology clinical and pharmaceutical sciences laboratories. Expected outcome The primary outcome will be change in mean (Median) CD 4 cell count. Secondary outcomes will be mean (or median) changes, viral load, complete blood count and other HIV associated immunological indices , Performance status and incidence of adverse effects like nausea, diarrhoea, weight gain and or loss. Expected benefits Adequate immunological recovery is one of the desired outcomes in HIV care. HAART combinations do not directly aid immunological recovery and some patients fail to have adequate immunological recovery despite adequate suppression of viral load. There are many patients using herbal supplements but there is limited scientific clinical evidence on the benefit of these supplements in HAART patients.
Status | Completed |
Enrollment | 250 |
Est. completion date | August 10, 2020 |
Est. primary completion date | August 10, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Participant is 18 years of age and above 2. Participant is HIV positive 3. Participant is on HAART first line for at least one year. 4. Participant is mentally sound 5. Participant is living within 60 km radius from the clinic and will be remaining within the radius of 60 km from the clinic during the study period h) Participant has a CD4 count less than 350cells/µl i.)Participant has normal haematological and biochemical indices J) ability to use phone SMS messaging K) Participant has signed the informed consent form Exclusion Criteria: 1. Participant is pregnant 2. Participant does not consent to study 3. Participant with opportunistic infection 4. Participants using other herbal medicines 5. Participant living outside the radius of 60 km from the clinic |
Country | Name | City | State |
---|---|---|---|
Uganda | Mbarara Regional Referral Hospital | Mbarara | SouthWestern |
Lead Sponsor | Collaborator |
---|---|
Mbarara University of Science and Technology | ANAMED |
Uganda,
Alin MH, Ashton M, Kihamia CM, Mtey GJ, Björkman A. Clinical efficacy and pharmacokinetics of artemisinin monotherapy and in combination with mefloquine in patients with falciparum malaria. Br J Clin Pharmacol. 1996 Jun;41(6):587-92. — View Citation
Ashton M, Gordi T, Trinh NH, Nguyen VH, Nguyen DS, Nguyen TN, Dinh XH, Johansson M, Le DC. Artemisinin pharmacokinetics in healthy adults after 250, 500 and 1000 mg single oral doses. Biopharm Drug Dispos. 1998 May;19(4):245-50. — View Citation
Zhao KC, Song ZY. [Pharmacokinetics of dihydroqinghaosu in human volunteers and comparison with qinghaosu]. Yao Xue Xue Bao. 1993;28(5):342-6. Chinese. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | CD4 counts | The primary outcome will be change in CD4 counts (absolute and relative) at 6 and 12 months in study participants following enrollment in the study. | Baseline, 6 and 12 months | |
Secondary | Viral load | Viral load at baseline, 6 and 12 months from time of initiating herbal treatment with the above mentioned herbs. | Baseline, 6 and 12 months | |
Secondary | Complete Blood Count | Complete Blood Count at baseline, 6 and 12 months | Baseline, 6 and 12 months | |
Secondary | Immunoglobins | Immunoglobins (E, A, G) associated with HIV infections in HAART patients at baseline, 6 and 12 months | Baseline, 6 and 12 months | |
Secondary | Antiretroviral plasma drug level | Antiretroviral plasma drug level in HAART patients at baseline and after one and two weeks | Baseline, one and two weeks | |
Secondary | Patients perceptions on mental and physical quality of life | WHO Quality of life Tool-HIV | Baseline, 6 and 12 months | |
Secondary | Liver function biomarkers | Liver function biomarkers at baseline, six and twelve months | Baseline, 6 and 12 months | |
Secondary | Side effects or adverse drug reactions | Incidence of side effects or adverse drug reactions in the study participants over the study period | Baseline, 12 months | |
Secondary | Renal function biomarkers | Renal function biomarkers at baseline, six and twelve months | Baseline, 6 and 12 months |
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 |
NCT06072443 -
AURORA Study-A Transformative Approach to Support PrEP Medication Persistence
|
||
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
|