HIV Infections Clinical Trial
Official title:
Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trials on the Effect of Combination of TCM and HAART on Immune Reconstitution of HIV/AIDS Patients
Immunity 1 (Fuzheng 1) is composed of herbs which have tonic and detoxific function. The long-term clinical application has proved the safety and effect. It can improve the symptoms and signs in AIDS patients with the effective rate of 70% and can significantly improve the quality of life. It can also improve and stabilize immune function and inhibit viral replication. The basis study have shown that Immunity 1 (Fuzheng 1) can inhibit viral replication from multi-target, multi-link, enhance immune function, increase the secretion of IL-2, IFN-γ, participate in immune regulation effect, enhance NK cell activity, promote CD3+CD4+T cell proliferation and increase macrophage phagocytes capacity.
- Meng Kun found that Joint application of Chuankezhi can enhance the number of CD4 cells
and reduce side-effects of HAART compared with HAART alone. in order to verify the
long-term efficacy of combination therapy, they carried out an clinical observations of
three cases of patients who received combination therapy for over a period of 3 years,
through the observation of three cases of patients, they found that CD3+CD4+T
lymphocyte count were significantly increased and HIV-RNA viral load were below
50copies for long-term, and without the occurrence of drug resistance. And the
patient's symptoms and signs have also been significantly improved.
- Duan Cheng Yu analyses 334 cases of AIDS patients' clinical symptoms, signs and
Karnofsky score, and CD3+CD4+ T lymphocyte count before and after treatment. The
patients all take "kang ai bao sheng" capsules for 3 months. The results showed that
334 cases of patients receiving traditional Chinese and western medicine treatment
shows improvement in symptoms and signs, increase in CD3+CD4+ T lymphocyte count. They
proposed that combination of traditional Chinese and western medicine can improve
symptoms, enhance immunity function and improve the quality of life of AIDS patients.
- In order to observe the effect of combination of TCM and HAART on HIV/AIDS patients,
ZHANG Ai-min divided 63 cases of AIDS into 3 groups. 20 cases received TCM treatment
and 22 cases received combination of TCM and HAART, 21 cases received western medicine.
The patients' symptoms, signs, Karnofsky score points, CD3+CD4+T lymphocyte counts and
HIV-RNA viral load were recorded and compare the difference between the 3 groups. The
results showed that combination treatment can more effectively improve the immune
function of HIV/AIDS patients, reduce HIV-RNA viral load, and improve the patients'
symptoms, signs and the quality of life.
- Immunity 1 (Fuzheng 1) is composed of herbs which have tonic and detoxific function.
The long-term clinical application has proved the safety and effect. It can improve the
symptoms and signs in AIDS patients with the effective rate of 70% and can
significantly improve the quality of life. It can also improve and stabilize immune
function and inhibit viral replication. The basis study have shown that Immunity 1
(Fuzheng 1) can inhibit viral replication from multi-target, multi-link, enhance immune
function, increase the secretion of IL-2, IFN-γ, participate in immune regulation
effect, enhance NK cell activity, promote CD3+CD4+T cell proliferation and increase
macrophage phagocytes capacity.
- Through the clinical trials, we are going to evaluate the efficacy and safety of
combination of TCM and HAART on immune reconstitution of HIV/AIDS patients.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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