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Strategies for Delivering Anti-HIV Therapy in South Africa Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Strategies for Delivering Anti-HIV Therapy in South Africa conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Strategies for Delivering Anti-HIV Therapy in South Africa Clinical research trials and Strategies for Delivering Anti-HIV Therapy in South Africa healthcare trials occur in a lot of 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 does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Strategies for Delivering Anti-HIV Therapy in South Africa. Strategies for Delivering Anti-HIV Therapy in South Africa Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Strategies for Delivering Anti-HIV Therapy in South Africa clinical trial. Test subjects typically receive the most effective healthcare possible for their Strategies for Delivering Anti-HIV Therapy in South Africa condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Strategies for Delivering Anti-HIV Therapy in South Africa  Strategies for Delivering Anti-HIV Therapy in South Africa
Strategies for Delivering Anti-HIV Therapy in South Africa
For Condition: HIV Infections
Status: Not yet recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: Providing effective anti-HIV therapy in developing countries is challenging. This study will evaluate new strategies for delivering anti-HIV medications to people in South Africa. These strategies include using specially trained nurses to administer therapy (rather than doctors), treating all HIV infected members of a household at the same time, and having community members observe patients taking their medications.
Details: The benefit of antiretroviral therapy is well established but limited to wealthy nations. A predefined, simple sequence of treatment regimens focused on extending the durability of limited treatment options has the best potential to be implemented in resource poor countries. South Africa has 15% of the world’s HIV/AIDS patients and a limited number of physicians to treat them (l per 1,600 and less than 5 infectious diseases specialists). HIV patient care in the primary care setting must therefore be delivered by personnel other than doctors. Further, treatment strategies should include entire households to ensure maximum adherence and minimize sharing of drugs. This study will have two parts. The first part will compare a first-line antiretroviral therapy regimen administered and monitored by primary health care sisters (nurses) with the same regimen administered by doctors. The second part of the study will determine if community-based directly observed therapy (DOT) is significantly superior to continued clinic-based treatment support for patients who have failed first-line therapy, as measured by cumulative virology failure rate. The project will also evaluate the cost and economic impact of a predetermined schedule of antiretroviral therapy; treatment outcomes in terms of morbidity, opportunistic and endemic infections, and mortality; and factors contributing to treatment failure, including toxicity, resistance, compliance, and treatment interruption. In Part 1, households will be randomly assigned to receive first-line antiretroviral therapy under the monitoring and care of either an HIV-trained medical doctor supported by adherence counselors or an HIV-trained primary health care sister (nurse with training in diagnosis and treatment prescription). Members of the household who are HIV infected will receive stavudine, lamivudine, and efavirenz (nevirapine or nelfinavir may be used for special populations). Participants who fail first-line antiretroviral therapy in Part 1 of the study will be entered into Part 2 of the study. Participants in Part 2 will receive zidovudine, didanosine, and lopinavir/ritonavir. Saquinavir/ritonavir will be substituted for lopinavir/ritonavir if the participant is receiving treatment for active tuberculosis. Participants will be randomly assigned to have their treatment monitored through either a clinic-based treatment support group or through community-based directly observed treatment (DOT). For the DOT arm, a community member will observe therapy for at least one dose a day, five days a week, at the home or work of the participant. HIV infected children age 3 months to 16 years who live in a participating household will also be included in the study. These children will receive first-line treatment with clinic visits monitored by either the assigned sister (nurse) or doctor along with their households. In Part 2, children will be provided with a second-line treatment regimen with continued daily monitoring of doses in the household. The study will last 5 years.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
Minimum Age/Maximum Age: 3 Months/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria for the first person in the household who enters the study: - HIV infected - Older than 16 years of age - History of a CDC Category C AIDS-defining illness or a CD4 cell count less than 350 cells/mm3 within 60 days prior to study entry - Have not previously taken anti-HIV medications. People who have taken anti-HIV medications for post-exposure prophylaxis or prevention of mother-to-child transmission may be eligible if the previous exposure did not exceed 6 weeks of nucleoside reverse transcriptase inhibitors or protease inhibitors, or two doses of a non-nucleoside reverse transcriptase inhibitor. Inclusion Criteria for children less than 16 years old in a household that has been entered in the study: - HIV infected - Live in house with an adult participating in the study - History of severe CDC Category B or C AIDS-defining illness, with the exception of a single episode of bacterial sepsis or a single episode of Zoster; or one CD4% less than 20% (less than 25% for children 3 to 18 months) obtained within 60 days prior to study entry - Have not previously taken anti-HIV medications. Children who have taken anti-HIV medications for post-exposure prophylaxis or prevention of mother-to-child transmission may be eligible if the previous exposure did not exceed 6 weeks of nucleoside reverse transcriptase inhibitors or protease inhibitors, or two doses of a non-nucleoside reverse transcriptase inhibitor therapy. Children who received 6 weeks of AZT or a single dose of nevirapine will be included in the study. - Consent of parent or legal guardian - Primary caregiver who is willing and able to administer anti-HIV medications Exclusion Criteria: - Newly diagnosed AIDS-defining (CDC Classification C) opportunistic infection or condition requiring acute therapy at the time of enrollment. A stable patient on therapy for more than 7 days may be enrolled. - Use of medications with significant effect on bone marrow, nervous system, pancreas, or liver within 30 days prior to study entry - Use of cytotoxic medications within 30 days prior to study entry - Active alcohol or substance abuse - Severe diarrhea (more than 6 stools/day for 7 consecutive days) within 30 days prior to study entry - Acute hepatitis within 30 days prior to study entry - Bilateral peripheral neuropathy of Grade 2 or greater at the time of screening - Women in the first trimester of pregnancy - Inability to tolerate oral medication - Any clinical condition that, in the opinion of the investigator, would make the person unsuitable for the study or unable to comply with the dosing requirements
Total Enrollment: 1050
Location and Contact Information:
University of the Witwatersrand/Clinical HIV Research Unit
Johannesburg, Gauteng, 2013
South Africa
Prudence Ive +27 11 274-9401/10
University of Cape Town/Masiphumelele
Cape Town, South Peninsula, 8005
South Africa
Catherine Orrell +27 21 650 6958
Additional Information:
Study ID Numbers: 5 U19 AI053217-02; CIPRA-SA Project 1
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00080522
Other Hiv Infections Studies:
1. A Comparison of Two Drug Combinations Used in HIV-Infected Patients Who Never Have Taken Anti-HIV Drugs
2. The Safety and Effectiveness of PMPA Prodrug in HIV-Infected Patients
3. A Multicenter Placebo-Controlled Double-Blind Trial to Evaluate Azidothymidine (AZT) Treatment of the AIDS Dementia Complex and Central Nervous System (CNS) Human Immunodeficiency Virus (HIV) Infection
4. Safety and Effectiveness of Giving Adefovir Dipivoxil Plus Abacavir Plus Efavirenz Plus Amprenavir to HIV-Infected Patients Who Have Failed to Respond to Previous Protease Inhibitor Treatment
5. A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of Subcutaneous Doses of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy
Related Studies:
Other HIV Infections Clinical Trials
Other Gauteng Clinical Trials
Other Johannesburg Clinical Trials
Strategies for Delivering Anti-HIV Therapy in South Africa
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