|
A Study of an Adherence Plan to Help HIV-Positive Patients Take Their First Anti-HIV Medications Correctly Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about A Study of an Adherence Plan to Help HIV-Positive Patients Take Their First Anti-HIV Medications Correctly conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Study of an Adherence Plan to Help HIV-Positive Patients Take Their First Anti-HIV Medications Correctly Clinical research trials and A Study of an Adherence Plan to Help HIV-Positive Patients Take Their First Anti-HIV Medications Correctly healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as A Study of an Adherence Plan to Help HIV-Positive Patients Take Their First Anti-HIV Medications Correctly. A Study of an Adherence Plan to Help HIV-Positive Patients Take Their First Anti-HIV Medications Correctly Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a A Study of an Adherence Plan to Help HIV-Positive Patients Take Their First Anti-HIV Medications Correctly clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their A Study of an Adherence Plan to Help HIV-Positive Patients Take Their First Anti-HIV Medications Correctly condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "A" Clinical Trials Conditions > A Study of an Adherence Plan to Help HIV-Positive Patients Take Their First Anti-HIV Medications Correctly  A Study of an Adherence Plan to Help HIV-Positive Patients Take Their First Anti-HIV Medications Correctly
A Study of an Adherence Plan to Help HIV-Positive Patients Take Their First Anti-HIV Medications Correctly
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 observed therapy can help HIV-positive patients stick to their anti-HIV medication schedule. Observed therapy means that a nurse will watch patients take their medications to make sure that they take them correctly. It is very important that HIV-positive patients take their anti-HIV medications correctly so they get the best possible benefit from them. Taking the drugs correctly, called "adherence," may keep HIV virus levels in the blood (viral load) low for a longer time. Adherence can also slow the development of drug resistance, and this is especially important in patients with early HIV infection who are just beginning treatment. However, anti-HIV medication schedules are often complicated, and many patients have difficulty remembering to take their drugs at the correct time. This study will look at the effectiveness of a plan to help patients with this problem.
Details: Novel approaches are needed to improve adherence to combination antiretroviral therapy. Nonadherence can lead to reduced drug levels and inadequate viral suppression, which accelerates drug resistance. Thus nonadherence in the first few months of primary HIV infection can limit therapeutic options for an individual years later. Barriers to optimal treatment adherence in patients with early HIV infection include complex treatment regimens which disrupt daily routines, drug intolerance, and concomitant illness including depression. Directly observed therapy has been successful in improving overall effectiveness of antituberculosis therapy and may be a useful strategy in HIV-infected patients. All patients receive combination antiretroviral therapy with didanosine (ddI), stavudine (d4T), efavirenz (EFV), and nelfinavir (NFV). Patients are randomized to self-administered (SAT) versus observed (MAT) therapy for 24 weeks. Patients randomized to MAT receive one directly observed dose (ddI, d4T, EFV, and NFV) of their antiretroviral regimen by a field worker or nurse at the clinic 5 days per week. As a reminder for the second NFV and d4T dose, MAT patients are provided with an alarm watch programmed to sound at dosing times. The alarm watch also serves as a reminder for weekend doses that will not be directly observed. Patients randomized to SAT receive standard care. All patients are monitored with monthly plasma HIV RNA levels and CD4 and CD8 cell counts. At Week 24, all patients are crossed over to SAT for an additional 48 weeks of follow-up.
Eligibility:
Study Type: Interventional, Treatment, Crossover Assignment
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Are HIV-positive. - Are at least 13 years old (consent is required if you are under 18). - Have a CD4 count of at least 200 cells/mm3 within 30 days of study entry. - Have never taken anti-HIV drugs. - Agree to practice effective methods of birth control. Exclusion Criteria Patients will not be eligible for this study if they: - Have cancer (except for Kaposi's sarcoma) that requires treatment. - Have a history of hepatitis or pancreatitis. - Have peripheral neuropathy. - Have an alcohol abuse problem. - Are pregnant or breast-feeding. - Are taking certain medications, such as rifabutin, rifampin, interleukin, or chemotherapy.
Total Enrollment: 74
Location and Contact Information:
Overall Study Official:
SusanLittle, Principal Investigator,
UCSD *Recruiting*
San Diego, California, 92103
United States
Recruiting Joanne Santangelo 619-543-8080
Univ of Texas Southwestern Med Ctr *Recruiting*
Dallas, Texas, 75235
United States
Recruiting Phillip Keiser 214-590-5182
Additional Information:
Study ID Numbers: AIEDRP AI-05-003; AEHIV 003: MAT
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001122
Other Hiv Infections Studies:
1. The Safety of Four Different Dose Levels of Wobenzym in HIV-Positive Patients
2. Prevalence of Hepatitis C Virus Infection in HIV-Infected Children
3. The Effects of Prednisone on HIV Levels and the Immune System
4. ALVAC-HIV vCP1452 Alone and Combined with MN rgp120
5. Rifabutin Therapy for the Prevention of Mycobacterium avium Complex (MAC) Bacteremia in AIDS Patients With CD4 Counts = or < 200: A Double-Blind, Placebo-Controlled Trial
Related Studies:
Other HIV Infections Clinical Trials
Other California Clinical Trials
Other San Diego Clinical Trials
A Study of an Adherence Plan to Help HIV-Positive Patients Take Their First Anti-HIV Medications Correctly
|
|
|
|
|
|
|
|
