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Five-Drug Anti-HIV Treatment Followed by Treatment Interruption in Patients Who Have Recently Been Infected with HIV 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 Five-Drug Anti-HIV Treatment Followed by Treatment Interruption in Patients Who Have Recently Been Infected with HIV conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Five-Drug Anti-HIV Treatment Followed by Treatment Interruption in Patients Who Have Recently Been Infected with HIV Clinical research trials and Five-Drug Anti-HIV Treatment Followed by Treatment Interruption in Patients Who Have Recently Been Infected with HIV 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 Five-Drug Anti-HIV Treatment Followed by Treatment Interruption in Patients Who Have Recently Been Infected with HIV. Five-Drug Anti-HIV Treatment Followed by Treatment Interruption in Patients Who Have Recently Been Infected with HIV 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 Five-Drug Anti-HIV Treatment Followed by Treatment Interruption in Patients Who Have Recently Been Infected with HIV clinical trial. Test subjects typically receive the most effective healthcare possible for their Five-Drug Anti-HIV Treatment Followed by Treatment Interruption in Patients Who Have Recently Been Infected with HIV 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 > "F" Clinical Trials Conditions > Five-Drug Anti-HIV Treatment Followed by Treatment Interruption in Patients Who Have Recently Been Infected with HIV  Five-Drug Anti-HIV Treatment Followed by Treatment Interruption in Patients Who Have Recently Been Infected with HIV
Five-Drug Anti-HIV Treatment Followed by Treatment Interruption in Patients Who Have Recently Been Infected with HIV
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: This study will determine what effect taking a combination of five anti-HIV drugs during the early stage of HIV infection, then temporarily stopping them once or twice, may have on the amount of HIV virus in the blood (viral load). The study will also evaluate the safety and effectiveness of this anti-HIV drug combination.
Details: Acute, primary HIV infection represents a potentially unique opportunity to eradicate the infection. Although plasma viral load rises rapidly, the dominant infecting virus is relatively uniform genetically, and infection may not be fully established in all tissue sites until some time after exposure. Current antiretroviral therapy is able to reduce plasma viral load to unmeasurable levels in established infection. However, there are many questions that remain about the treatment of primary HIV infection. While it is assumed that aggressive antiretroviral regimens are required, it is not known how long they must be continued. It is hoped that after an interval of aggressive therapy, the number of agents could be safely reduced. This study evaluates if viral suppression can be sustained after study therapy is withdrawn. Participants in this study will receive lamivudine (3TC), stavudine (d4T), abacavir (ABC), amprenavir (APV), and ritonavir (RTV) for at least 52 weeks. During this induction phase, participants will be followed through regular study visits every 4 or 8 weeks. If the participant’s viral load and CD4 counts are within study parameters at the end of 52 weeks, the participant will discontinue all antiretroviral medications simultaneously. Participants in the treatment interruption phase will be followed weekly initially, every 2 weeks for 8 weeks, and then every 4 or 8 weeks. Treatment may be restarted if necessary during this phase based on viral load and CD4 counts. If treatment is restarted, the participant will receive 3TC, d4T, APV, and RTV but not ABC. During this reinduction phase, participants will be followed every 4 or 8 weeks. Depending on viral load and CD4 counts, participants may be eligible for a second treatment interruption phase following the reinduction phase. Participants will once again stop all antiretroviral medications simultaneously and will have the same monitoring as in the first treatment interruption phase. Following this second treatment interruption, participants will be restarted on 3TC, d4T, APV, and RTV and will be evaluated at Weeks 4, 8, 16, and 24, at which time participants go off study. The length of study participation for individual participants will vary. The length of each phase will be highly dependent on the participant’s laboratory parameters. In general, participants will be enrolled in the study for 3 to 4 years. Participants may also enroll in immunology, compartment, pharmacology, and medication compliance substudies.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Acute HIV infection (recently infected with HIV or recent seroconversion) - Karnofsky status of 80 or greater within 14 days prior to study entry - Acceptable methods of contraception - Able and willing to give written informed consent Exclusion Criteria: - Previously received anti-HIV drugs - Hepatitis within 30 days prior to study entry - Pancreatitis within 120 days prior to study entry - Radiation or chemotherapy within 30 days prior to study entry - Certain medications within 14 days prior to study entry - Experimental or investigational therapy within 30 days prior to study entry - Illness (non-HIV infection, cancer, etc.) at the time of study entry - Pregnant or breastfeeding
Total Enrollment: 121
Location and Contact Information:
Overall Study Official:
PaulVolberding, Study Chair, San Francisco Veterans Medical Center
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Washington Univ (St. Louis)
St. Louis, Missouri, 63108-2138
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
Univ of Hawaii
Honolulu, Hawaii, 96816
United States
Miriam Hosp / Brown Univ
Providence, Rhode Island, 02906
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Univ of Puerto Rico
San Juan, , 009365067
Puerto Rico
Presbyterian Med Ctr- Univ of PA
Norristown, Pennsylvania, 19401
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Chelsea Ctr
New York City, New York, 10021
United States
Cornell Univ Med Ctr
New York City, New York, 10021
United States
Community Health Network Inc
Rochester, New York, 14642
United States
Univ of North Carolina
Chapel Hill, North Carolina, 27514
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
St Mary's Hosp (Univ of Rochester/Infectious Diseases)
Rochester, New York, 14642
United States
Additional Information:
Study ID Numbers: ACTG 371; ACTG 710 (substudy),ACTG 711 (substudy),ACTG 729 (substudy),ACTG 709 (substudy),AACTG 371
Study Start Date: March 1997
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000940
Other Hiv Infections Studies:
1. Comparison of ddI Versus Zidovudine in HIV-Infected Patients
2. The Effect of Anti-HIV Therapy on Fat Metabolism in HIV-Positive Patients
3. Comparing Standard-Dose Versus Adjusted-Dose Lopinavir/Ritonavir Therapy in HIV-Infected Persons with Drug Resistance
4. A Study to Evaluate the Use of a Protease Inhibitor and of Interleukin-2 (IL-2) in the Treatment of Early HIV Infection
5. Safety of and Immune System Response to an HIV Vaccine (EP-HIV-1090) in HIV Infected Patients
Related Studies:
Other HIV Infections Clinical Trials
Other New York Clinical Trials
Other Rochester Clinical Trials
Five-Drug Anti-HIV Treatment Followed by Treatment Interruption in Patients Who Have Recently Been Infected with HIV
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