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Testosterone for HIV-Positive Men with Reduced Serum Testosterone Levels and Abdominal Fat Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Testosterone for HIV-Positive Men with Reduced Serum Testosterone Levels and Abdominal Fat conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Testosterone for HIV-Positive Men with Reduced Serum Testosterone Levels and Abdominal Fat Clinical research trials and Testosterone for HIV-Positive Men with Reduced Serum Testosterone Levels and Abdominal Fat health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Testosterone for HIV-Positive Men with Reduced Serum Testosterone Levels and Abdominal Fat. Testosterone for HIV-Positive Men with Reduced Serum Testosterone Levels and Abdominal Fat Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Testosterone for HIV-Positive Men with Reduced Serum Testosterone Levels and Abdominal Fat clinical trial. Test subjects typically receive the most expert healthcare available for their Testosterone for HIV-Positive Men with Reduced Serum Testosterone Levels and Abdominal Fat condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > Testosterone for HIV-Positive Men with Reduced Serum Testosterone Levels and Abdominal Fat  Testosterone for HIV-Positive Men with Reduced Serum Testosterone Levels and Abdominal Fat
Testosterone for HIV-Positive Men with Reduced Serum Testosterone Levels and Abdominal Fat
For Condition: HIV Infections
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to see if treatment with testosterone will reduce abdominal fat in HIV-positive men. Many HIV patients on antiretroviral therapy show an increase in abdominal fat. Studies have shown that treatment with testosterone may decrease abdominal fat. This study will determine if testosterone will reduce abdominal fat in HIV patients.
Details: Reports suggest that many HIV-infected patients on antiretroviral therapy experience an increase in abdominal fat. The mechanisms of abdominal fat accumulation in HIV-infected patients are not known. Studies have shown: treatment with testosterone gel reduces total body fat in young, androgen-deficient men; testosterone replacement in middle-aged men with mid-segment obesity decreases visceral fat; and replacement doses of testosterone decrease fat mass and augment lean body mass in HIV-infected men with androgen deficiency. Therefore, there is a strong rationale for evaluating the effectiveness of testosterone replacement in HIV-infected men with visceral obesity and low testosterone levels. Patients are stratified based on their viral load. Patients receive either testosterone gel or placebo applied to the skin once daily for 24 weeks. Patients remain on their current antiretroviral regimens, which are not supplied through the study. Patients who receive testosterone during the first 24 weeks are eligible to receive it for an additional 24 weeks. Patients on placebo are followed for an additional 24 weeks. Clinical and laboratory evaluations for visceral fat changes are performed throughout the study.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind
Minimum Age/Maximum Age: 18 Years/70 Years
Genders: Male
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Are HIV-positive. - Have been taking anti-HIV medications for at least 12 weeks before study entry and plan to continue taking them for an additional 24 weeks. - Are male and between 18 and 70 years old. - Have a measurement of greater than 100 cm around the abdomen. - Can report an increase in abdominal size after taking antiretroviral drugs. - Have a viral load less than 10,000 copies/ml within 6 weeks prior to screening. - Have a serum total testosterone between 125 and 400 ng/dl. If serum total testosterone is greater than 400 ng/dl, bioavailable testosterone must be less than 115 ng/dl or free testosterone must be less than 50 pg/ml. Exclusion Criteria Patients will not be eligible for this study if they: - Take certain drugs, including testosterone derivatives, glucocorticoids, appetite stimulants, dronabinol, megestrol acetate, androstenediols, oxandrolone, or other anabolic agents such as dehydroepiandrosterone (DHEA) or growth hormone within 12 weeks prior to study entry. - Take hydroxyurea within 30 days of study entry. - Take drugs for diabetes. - Have diabetes. - Take granulocyte-macrophage colony-stimulating factor (GM-CSF). (Granulocyte colony-stimulating factor (G-CSF) is allowed.) - Take cytokines, cytokine inhibitors, or ketoconazole. - Take ritonavir with simvastatin or lovastatin. - Have an active opportunistic infection. Patients on treatment for at least 12 weeks will be allowed. - Have 5-7 loose stools per day or diarrhea for more than 1 week, within 6 weeks of study entry. - Have a blood pressure greater than 160 over 100. - Have certain heart problems. - Have a breast mass that has not been diagnosed. - Have active cancer. - Have had prostate cancer or certain other prostate problems. - Are allergic to any part of the testosterone gel. - Have a history of blood clots. - Have a history of sleep apnea. - Are receiving experimental treatment. - Are receiving experimental drugs in other studies and do not know if they are taking the drug or placebo. - Abuse drugs or alcohol in a way that would interfere with the study. - Are dieting or doing heavy exercising. - Have a viral load of 10,000 copies/ml or more at screening
Total Enrollment: 86
Location and Contact Information:
Overall Study Official:
ShalenderBhasin, Study Chair,
Washington Univ / St Louis Connect Care *No longer recruiting*
St. Louis, Missouri, 63108
United States
No longer recruiting
Methodist Hosp of Indiana / Life Care Clinic *Recruiting*
Indianapolis, Indiana, 46202
United States
Recruiting Sarah Ryan 317-929-2917
Washington Univ School of Medicine *Recruiting*
St. Louis, Missouri, 63108
United States
Recruiting Michael Klebert 314-454-0058
Univ of Colorado Health Sciences Ctr *Recruiting*
Denver, Colorado, 80262
United States
Recruiting M Ray 303-372-5535
Univ of Puerto Rico *Recruiting*
San Juan, , 009365067
Puerto Rico
Recruiting Virginia Ramirez 787-767-9192
Wishard Hosp *Recruiting*
Indianapolis, Indiana, 46202
United States
Recruiting Scott Hamilton 317-630-6023
Stanford Univ Med Ctr *No longer recruiting*
Stanford, California, 943055107
United States
No longer recruiting
Univ of Pittsburgh *No longer recruiting*
Pittsburgh, Pennsylvania, 15213
United States
No longer recruiting
Bellevue Hosp / New York Univ Med Ctr *Recruiting*
New York City, New York, 10016
United States
Recruiting Maura Laverty 212-263-6565
Queens Med Ctr *Recruiting*
Honolulu, Hawaii, 96816
United States
Recruiting Debra Ogata-Arakaki 808-737-2751
Indiana Univ Hosp *Recruiting*
Indianapolis, Indiana, 462025250
United States
Recruiting Beth Zwickl 317-274-8456
Willow Clinic *No longer recruiting*
Menlo Park, California, 94025
United States
No longer recruiting
Univ of Cincinnati *No longer recruiting*
Cincinnati, Ohio, 452670405
United States
No longer recruiting
Rush Presbyterian - Saint Luke's Med Ctr *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Jan Fritsche 312-942-5865
Univ of California San Francisco *Recruiting*
San Francisco, California, 94110
United States
Recruiting Julieann Lewis 415-514-0550
Univ of Nebraska Med Ctr *Recruiting*
Omaha, Nebraska,
United States
Recruiting Frances Meter 402-559-8163
Univ of Pennsylvania *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Joseph Quinn 215-349-8092
Northwestern Univ Med School *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting Baiba Berzins 312-695-5012
Univ of Minnesota *Recruiting*
Minneapolis, Minnesota, 55455-0392
United States
Recruiting Christine Fietzer 612-625-1462
Univ of Hawaii *Recruiting*
Honolulu, Hawaii, 96816
United States
Recruiting Debra Ogata-Arakaki 808-737-2751
San Mateo AIDS Program / Stanford Univ *No longer recruiting*
Stanford, California, 943055107
United States
No longer recruiting
Univ of California, San Diego *Recruiting*
San Diego, California, 92103
United States
Recruiting Jill Kunkel 619-543-8080
Univ of Southern California / LA County USC Med Ctr *No longer recruiting*
Los Angeles, California, 900331079
United States
No longer recruiting
Additional Information:
Study ID Numbers: ACTG A5079; AACTG 5079
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00009555
Other Hiv Infections Studies:
1. Metformin and Rosiglitazone, Alone or in Combination, in HIV-Infected Patients with Insulin and Fat Abnormalities
2. Randomized Comparative Study of Fluconazole Versus Clotrimazole Troches in the Prevention of Serious Fungal Infection in Patients With AIDS or Advanced AIDS-Related Complex. (A Nested Study of ACTG 081)
3. Depo-Medroxyprogesterone Acetate (DMPA, Depo-Provera) Use with Certain Anti-HIV Drugs in HIV-Infected Women
4. Massage to Increase Well-Being and Immune Function in Dominican Children Infected With HIV
5. A Study of the Safety and Effectiveness of Different Doses of 1592U89 in HIV-Infected Patients
Related Studies:
Other HIV Infections Clinical Trials
Other Indiana Clinical Trials
Other Indianapolis Clinical Trials
Testosterone for HIV-Positive Men with Reduced Serum Testosterone Levels and Abdominal Fat
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