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Home > "E" Clinical Trials Conditions > Effects of Changing HIV Therapy at Lower Versus Higher Viral Loads  Effects of Changing HIV Therapy at Lower Versus Higher Viral Loads
Effects of Changing HIV Therapy at Lower Versus Higher Viral Loads
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: This study will look at people who have been taking anti-HIV drugs but still have detectable levels of HIV. The purpose of the study is to find out what happens in those people who change anti-HIV drugs when their viral load reaches 200 copies compared to those who change anti-HIV drugs when their viral load reaches 10,000 copies. This study will also look at drug resistance (how well HIV responds to drugs), viral fitness (how well drug-resistant HIV copies itself), and immunologic reconstitution (how well the immune system recognizes various infections, including HIV). Many patients experience virologic relapse (increase in viral load after sustained viral load suppression) within 1 to 2 years of taking anti-HIV drugs. The approach to treatment for patients who experience virologic relapse while on a highly active antiretroviral therapy (HAART) has not been defined. Current guidelines recommend switching to a new treatment regimen as soon as possible to prevent HIV from becoming even more resistant to anti-HIV drugs. However, there is evidence that patients can benefit from staying on the same HAART drugs, even after virologic relapse. This study wants to find what happens when drugs are changed immediately after virologic relapse (when the viral load is lower) compared to what happens if drugs are changed only after a delay (when the viral load is higher).
Details: Virologic relapse occurs within 1 to 2 years of antiretroviral therapy in up to 50 percent of HIV-infected individuals. The best treatment approach for patients who experience virologic rebound while on highly active antiretroviral therapy (HAART) has not been defined. Current guidelines recommend switching to a new treatment regimen shortly after virologic rebound in an effort to avoid sequential accumulation of multiple resistance mutations. However, early treatment switching has numerous disadvantages: risk of virologic rebound on the new therapy, a limited number of drug combinations available to treat such rebounds, and difficulty in obtaining early genotypic and phenotypic drug-resistance information to guide treatment modification. Delaying a switch to a new antiretroviral regimen has the advantage of preserving future treatment options, and HIV levels may remain partially suppressed even after drug-resistant mutants emerge. Moreover, several observational studies describe maintenance of immunologic and clinical benefits of HAART even after virologic rebound. Delayed treatment switches, however, raise concerns about sequential accumulation of drug resistance mutations that may diminish the chances of viral resuppression with successive HAART regimens, and the long-term immune consequences of virologic rebound on HAART are not known. It is therefore important to evaluate the viral and immunologic responses among patients randomized to either an early or delayed HAART switch. This study enrolls patients who have a viral load of at least 200, but less than 10,000 copies/ml. The patients are randomized into 2 treatment arms. Arm A (immediate switch) patients have genotypic resistance testing at entry. Based on the resistance test results, their antiretroviral treatment regimen is modified to a switch treatment regimen. Switch treatment initiates no later than Week 4. Arm B (delayed switch) patients continue their current antiretroviral regimen and have genotypic resistance testing when their plasma HIV-1 RNA levels reach 10,000 copies/ml or greater. Based on the resistance test results, their antiretroviral treatment regimen is modified to a switch treatment regimen. Switch treatment initiates no later than 4 weeks from the date of at least 10,000 copies/ml viral load, or from the date of an absolute CD4 count reduced by 20 percent from baseline value. Patients who never meet the switch criteria remain on study. All patients are followed for a minimum of 48 weeks after entry. No antiretroviral drugs are provided by the study.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Are HIV-infected. - Have a CD4 cell count of 200 cells/mm3 or more within 45 days prior to entry. - Are currently receiving the same HAART regimen for at least 4 months. - Had a documented viral load of less than 500 copies/ml at any time prior to screening on the current stable antiretroviral regimen. - Have a detectable plasma viral load on current stable anti-HIV regimen, as defined in the protocol, within 52 weeks prior to screening. - Are willing to remain on their current regimen until their scheduled switch. - Have a negative pregnancy test within 48 hours prior to entry. - Are at least 13 years old. - Agree not to participate in the conception process (active attempts to become pregnant or to make someone pregnant) while on study and for 60 days after going off study. - Agree to use 2 acceptable forms of contraception while on study and for 60 days after going off study. Exclusion Criteria Patients may not be eligible for this study if they: - Do not adhere with current antiretroviral therapy. - Have an infection or cancer that requires treatment within 45 days prior to entry. - Are pregnant or breast-feeding. - Have used any experimental agents, systemic corticosteroids, or drugs that interfere with the immune system within 45 days prior to entry. - Have received any HIV vaccine within 90 days prior to entry. - Use drugs or alcohol that, in the opinion of the investigator, would interfere with the study.
Total Enrollment: 108
Location and Contact Information:
Overall Study Official:
SharonRiddler, Study Chair,
Harbor General/UCLA
Torrance, California, 90502-2052
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
San Mateo AIDS Program / Stanford Univ
Stanford, California, 94305-5107
United States
Northwestern Univ
Chicago, Illinois, 60611
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Univ of North Carolina
Chapel Hill, North Carolina, 27599-7215
United States
Univ of Hawaii
Honolulu, Hawaii, 96816
United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405
United States
Univ of Texas Galveston
Galveston, Texas, 775550435
United States
Harvard (Masschusetts General Hosp)
Boston, Massachusetts, 02114
United States
Willow Clinic
Menlo Park, California, 94025
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Stanford Univ Med Ctr
Stanford, California, 94305-5107
United States
Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
Univ of Texas, Southwestern Med Ctr of Dallas
Dallas, Texas, 75390
United States
Comprehensive Care Clinic / Vanderbilt Univ Med Ctr
Nashville, Tennessee, 37203
United States
Brown Univ / Miriam Hosp
Providence, Rhode Island, 02906
United States
Miriam Hosp / Brown Univ
Providence, Rhode Island, 02906
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
The CORE Ctr
Chicago, Illinois, 60612
United States
Brigham and Womens Hosp
Boston, Massachusetts, 02215
United States
Univ of Washington
Seattle, Washington, 98104
United States
Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
Additional Information:
Study ID Numbers: ACTG A5115; AACTG A5115
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00036465
Other Hiv Infections Studies:
1. A Phase I/II Clinical Study of WF 10 IV Solution ( TCDO ) in Patients With HIV Infection
2. A Comparison of Fluconazole and Amphotericin B in the Treatment of Cryptococcal Meningitis
3. A Collection of Data from Adult AIDS Clinical Trials
4. Safety of an HIV Vaccine (AVX101) in HIV Uninfected Volunteers in the United States and South Africa
5. A Study of HIV in Newly Infected Individuals
Related Studies:
Other HIV Infections Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Effects of Changing HIV Therapy at Lower Versus Higher Viral Loads
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