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Immunoglobulins

David A. Wohl

Ann C. Collier

William G. Powderly

Charles S. Rabkin

The purpose of this study is to find out why cancers develop in HIV-positive patients.

Cancer is a leading cause of death in AIDS patients. Common cancers in HIV-infected patients include Kaposi's sarcoma (KS) and non-Hodgkin's lymphoma (NHL), a cancer of the immune system. Risk factors include certain chemicals, viruses, and perhaps even anti-HIV drugs. Doctors would like to find out which risk factors are most important and how they relate to cancer in AIDS patients.

AIDS-associated malignancy represents a model system for investigations of carcinogenesis. There are few human conditions in which cancer rates are of the magnitude they are in HIV infection. While studies have investigated pre-cancer markers in HIV-infected patients, they have not correlated these markers with tumor samples. This study contributes to understanding oncogenesis of HIV-associated malignancies by establishing a collection of tumors linked with pre-cancer sera and lymphocyte specimens, as well as prospective questionnaire data.

At study entry, patients receive a comprehensive physical exam. Clinic staff interview the patient to collect data regarding medication history (particularly antiretroviral exposure), diet, occupational history, substance abuse, and sexual practices. This information is used to identify behavioral and environmental factors contributing to oncogenesis. In addition, baseline blood samples are analyzed for HHV-8 and EBV levels, anti-EBV and anti-HHV-8 antibodies, CD23, Th2 cytokines, tumor growth factors, chromosomal translocations associated with NHL, and other potential predictors of malignancy. At Month 6 and annually thereafter, patient records are abstracted for data on vital status, AIDS-defining illnesses, medications, and most recent CD4+ T cell and HIV RNA levels. At Years 1, 2, and 3, patients undergo physical exams and blood tests for malignancy surveillance. Any malignancies are biopsied and analyzed for oncogene identification and virology. The medical records of patients who die on study are reviewed to determine the cause of death and to rule out unreported cancer. No treatment is provided by this study.

A Study of Patients With AIDS Syndrome

Oncogenic Viral Pathogenesis and Cancer Risk Factors Among Patients With the Acquired Immunodeficiency Syndrome: A Prospective Cohort Study

National Cancer Institute (NCI)

National Institute of Allergy and Infectious Diseases (NIAID)

Nutritional and Metabolic Diseases

Skin and Connective Tissue Diseases

Necrosis

Wasting Syndrome

Cachexia

Lipodystrophy

HIV Wasting Syndrome

Skin Diseases

Skin Diseases, Metabolic

Metabolic Diseases

Lipid Metabolism Disorders

Weight Loss

Body Weight

Body Weight Changes

Thinness

Nutrition Disorders

Anti-Infective Agents

Anti-Retroviral Agents

Anti-HIV Agents

Caroline Chantry

Joseph Cervia

The purpose of this study is to see how beginning or changing anti-HIV medications affects the body composition (weight, height, growth, body fat, and muscle mass, or fat and muscle distribution) of HIV-infected children. This study also looks at how changes in body composition relate to changes in viral load (level of HIV in the blood), CD4 cell counts, height, and weight in HIV-infected children. This study also compares changes in body composition to levels of cytokines (proteins in the body that affect some immune cells) in HIV-infected children who are beginning or changing anti-HIV therapy.

Though studies have been done on adults, little is known about the effects of HIV infection and anti-HIV drugs on body composition in children. One theory is that changes in body composition can predict the failure of anti-HIV treatment. If this is true, body composition measurements can be as useful as CD4+ cell counts in determining drug effectiveness.

Despite accumulating data in adults, little information is available regarding the effects of HIV infection and antiretroviral therapy on body composition in children. Preliminary information indicates that lean body mass is lost in preference to fat mass in HIV-infected children, supporting the theory that failure to thrive in HIV infection is often cytokine mediated. It can be hypothesized that changes in body composition (lean body mass) may predict changes in weight growth velocity and may give an early clinical indication of treatment failure. If so, body composition measurement may yield an additional outcome measure for clinical trials, equivalent in utility to other laboratory measures of treatment response, e.g., persistent CD4+ cell count changes. Additionally, if body composition changes are highly correlated with responses in viral load, body composition may prove to be a more affordable measure of antiretroviral effectiveness in developing countries.

This study is a nonrandomized, observational study. Children are recruited to each of 4 age strata:

Stratum A: 1 month to 18 months. Stratum B: greater than 18 months to 3 years. Stratum C: greater than 3 years to 8 years. Stratum D: greater than 8 years to less than 13 years. Children beginning or changing antiretroviral therapy and fulfilling the study specifications may be enrolled in the study. Children have 5 outpatient clinic visits, at entry and at 12, 24, 36, and 48 weeks, for anthropometry, body composition by bioelectrical impedance analysis, cytokine levels, viral load, CD4+ cell count, and markers of lipid and glucose metabolism.

The Effect of Anti-HIV Treatment on Body Characteristics of HIV-Infected Children

Effect of Antiretroviral Therapy on Body Composition in HIV-Infected Children

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Recurrence

Papillomavirus Infections

Disease Attributes

Tumor Virus Infections

In the enrollment, women whose cervical histopathological results have been diagnosed as high-grade squamous intraepithelial lesion (HSIL) for the last 3 months with abnormal results will be included in this study. All participants will be followed up three times, at 6 months,12 months and 24 months.

Participants will be followed up at 6, 12 and 24 months with HPV viral load tests, Thinprep cytologic tests (TCT) and vaginal secretion tests.

Follow-up

Binhua Dong

Fang Xie, M.D

Wenfang Jin

Xianqian Chen

Yuchun' Lv, M.D

Feifeng Shi, M.D

Jinyong Wang

Zheng Zheng

Hongning Cai

Qing Li

Pengming Sun, PhD

Human papillomavirus (HPV) infection has become one of the most important health problems faced by women all over the world. A large number of studies have shown that women's cervical, vaginal and perianal precancerous lesions, related cancers, condyloma acuminatum and other sexually transmitted diseases (STD) are closely related to HPV infection. Among them, the persistent infection of high-risk human papillomavirus (HR-HPV) is closely related to the occurrence of invasive cervical cancer. Previous studies have shown that there are significant differences in the effects of multiple HPV infection and persistent infection of different types (such as type-16, -18, -39 and -52) on different levels of cervical lesions, and there is a certain correlation between HPV load in the process of persistent infection and the degree of cervical lesions. In addition, other studies have shown that HPV-16 viral load has certain clinical significance in predicting Cin2 / CIN3 high-grade cervical lesions, and HPV viral load level is significantly different in cervical low-grade squamous intraepithelial lesion (LSIL) and cervical high-grade squamous intraepithelial lesion (HSIL). The above biological changes such as HPV infection type, quantity and proportion can promote the occurrence and development of cervical precancerous lesions and related cancers to varying degrees. It can be seen that the study of the relationship between HPV viral load and cervical lesions is of great significance for clinical disease development prediction and cervical cancer screening.

Based on previous studies and clinical practice, this study carried out a multi center cohort study in China. In this study, ten research including Fujian Maternity and Child Health Hospital, Mindong Hospital of Ningde City, Zhangzhou affiliated Hospital of Fujian Medical University, Quanzhou First Hospital Afflicated to Fujian Medical University, The First Hospital of Putian City, Ningde Municipal Hospital of Ningde Normal University, Shenzhen Maternity and child Healthcare Hospital and Maternity and child Hospital of Hubei Province were included, each of which included 400 individuals, with a total of 4000 women with high-grade squamous intraepithelial lesion were enrolled. For the first time, the investigators will collect 2 samples of cervical exfoliated cells and 4 samples of vaginal fornix swabs from participants, then at the 6th, 12th and 24th months after the first sampling, the participants need to return to the hospital, collected 2 samples of cervical exfoliated cells and 4 samples of vaginal fornix swabs again in order to observe and record the development of the disease. During this process, if abnormal cervical lesions are found, the participants will be biopsied under colposcopy according to relevant guidelines. Samples from cervix would be sent for PCR-sequencing, HPV tests and Thinprep cytologic test (TCT). And samples from vaginal fornix would be sent for sequencing and bioinformatic analysis. A prospective cohort study was conducted to explore the correlation between the characteristics, progression and prognosis of female genital tract lesions and HPV infection type, load and vaginal microenvironment.

DNA samples from cervix and vaginal fornix \& cell samples from cervix

A Multicenter Cohort Study of HPV Viral Load in Predicting the Postoperative Recurrence of HSIL

A Multicenter Cohort Study of HPV Viral Load in Predicting the Postoperative Recurrence of Women With HSIL in Cervix

Cervical histopathology was performed at baseline for all participants.

Cervical histopathology was performed at 6-month follow-up for cervical HPV infection or cytology abnormalities women.

Cervical histopathology was performed at 12-month follow-up for cervical HPV infection or cytology abnormalities women.

Cervical histopathology was performed at 24-month follow-up for cervical HPV infection or cytology abnormalities women.

Human Papillomavirus (HPV) viral load test was performed at baseline for all participants.

All participants were tested for HPV viral load at the time of 6-month follow-up.

All participants were tested for HPV viral load at the time of 12-month follow-up.

All participants were tested for HPV viral load at the time of 24-month follow-up.

All participants were tested for cervical cytology at the time of baseline.

All participants were tested for Cervical cytology testing at the time of 6-month follow-up.

All participants were tested for Cervical cytology testing at the time of 12-month follow-up.

All participants were tested for Cervical cytology testing at the time of 24-month follow-up.

All participants underwent vaginal secretion sequencing at baseline.

All participants underwent vaginal secretion sequencing at the time of 6-month follow-up.

All participants underwent vaginal secretion sequencing at the time of 12-month follow-up.

All participants underwent vaginal secretion sequencing at the time of 24-month follow-up.

All participants underwent Human Papillomavirus (HPV) genotyping tests at baseline.

All participants underwent Human Papillomavirus (HPV) genotyping tests at the time of 6-month follow-up.

All participants underwent Human Papillomavirus (HPV) genotyping tests at the time of 12-month follow-up.

All participants underwent Human Papillomavirus (HPV) genotyping tests at the time of 24-month follow-up.

Fujian Maternity and Child Health Hospital

Principal Investigator

In the enrollment, women whose cervical histopathological results have been diagnosed as low-grade squamous intraepithelial lesion (LSIL) for the last 3 months with abnormal results will be included in this study. All participants will be followed up three times, at 6 months,12 months and 24 months.

Follow up

Qing Li, M.D

Shaomei Lin

Zheng Zheng, M.D

Hongning Cai, M.D

Based on our previous studies and clinical practice, this study carried out a multi center cohort study in Fujian Province, China. In this study, six research including Fujian Maternity and Child Health Hospital, Mindong Hospital of Ningde City, Zhangzhou affiliated Hospital of Fujian Medical University, Quanzhou First Hospital Afflicated to Fujian Medical University, Xiamen Maternity and Child Health Hospital Affiliated to Xiamen University and Ningde Municipal Hospital of Ningde Normal University were included, each of which included 500 individuals, with a total of 3000 women with low-grade squamous intraepithelial lesion were enrolled. For the first time, the researchers will collect 2 samples of cervical exfoliated cells (one of which will be sub packed into 3) and 4 samples of vaginal fornix swabs from subjects, then at the 6th, 12th and 24th months after the first sampling, the subjects need to return to the hospital, collect 2 samples of cervical exfoliated cells (one of which will be sub packed) and 4 samples of vaginal fornix swabs again in order to observe and record the development of the disease. During this process, if abnormal cervical lesions are found, the subjects will be biopsied under colposcopy according to relevant guidelines. Samples from cervix would be sent for PCR-sequencing, HPV tests and Thinprep cytologic test (TCT). And samples from vaginal fornix would be sent for sequencing and bioinformatic analysis. A prospective cohort study was conducted to explore the correlation between the characteristics, progression and prognosis of female genital tract lesions and HPV infection type, load and vaginal microenvironment.

HPV Viral Load in Predicting the Prognosis of LSIL

A Multicenter Cohort Study of HPV Viral Load in Predicting the Prognosis of Women With LSIL in Cervix

All participants underwent tests for vaginal microbiota at baseline.

All participants underwent tests for vaginal microbiota at the time of 6-month follow-up.

All participants underwent tests for vaginal microbiota at the time of 12-month follow-up.

All participants underwent tests for vaginal microbiota at the time of 24-month follow-up.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Patients With AIDS Syndrome	NCT00001120	Sarcoma, Kaposi Lymphoma, Non-H... HIV Infections Lymphoma, AIDS-...		18 Years -	National Institute of Allergy and Infectious Diseases (NIAID)
The Effect of Anti-HIV Treatment on Body Characteristics of HIV-Infected Children	NCT00006064	HIV Infections HIV Wasting Syn... Lipodystrophy		1 Month - 12 Years	National Institute of Allergy and Infectious Diseases (NIAID)
A Multicenter Cohort Study of HPV Viral Load in Predicting the Postoperative Recurrence of HSIL	NCT05282745	HPV Infection HSIL, High-Grad... Viral Load	Follow-up	20 Years -	Fujian Maternity and Child Health Hospital
HPV Viral Load in Predicting the Prognosis of LSIL	NCT05051852	HPV Infection LSIL, Low-Grade... Viral Load	Follow up	20 Years -	Fujian Maternity and Child Health Hospital

Spots Global Cancer Trial Database for viral load

Every month we try and update this database with for viral load cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for viral load

Every month we try and update this database with for viral load cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for viral load cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.