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Vaccine (ALVAC-HIV vCP1452) Use and Intermittent Withdrawal of Anti-HIV Drugs in Patients with HIV 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 Vaccine (ALVAC-HIV vCP1452) Use and Intermittent Withdrawal of Anti-HIV Drugs in Patients with HIV conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Vaccine (ALVAC-HIV vCP1452) Use and Intermittent Withdrawal of Anti-HIV Drugs in Patients with HIV Clinical research trials and Vaccine (ALVAC-HIV vCP1452) Use and Intermittent Withdrawal of Anti-HIV Drugs in Patients with HIV 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 Vaccine (ALVAC-HIV vCP1452) Use and Intermittent Withdrawal of Anti-HIV Drugs in Patients with HIV. Vaccine (ALVAC-HIV vCP1452) Use and Intermittent Withdrawal of Anti-HIV Drugs in Patients with HIV 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 Vaccine (ALVAC-HIV vCP1452) Use and Intermittent Withdrawal of Anti-HIV Drugs in Patients with HIV clinical trial. Test subjects typically receive the most expert healthcare available for their Vaccine (ALVAC-HIV vCP1452) Use and Intermittent Withdrawal of Anti-HIV Drugs in Patients with HIV 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 > "V" Clinical Trials Conditions > Vaccine (ALVAC-HIV vCP1452) Use and Intermittent Withdrawal of Anti-HIV Drugs in Patients with HIV  Vaccine (ALVAC-HIV vCP1452) Use and Intermittent Withdrawal of Anti-HIV Drugs in Patients with HIV
Vaccine (ALVAC-HIV vCP1452) Use and Intermittent Withdrawal of Anti-HIV Drugs in Patients with HIV
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: Long-term control of HIV depends on improvement in an individual's immune system. The purpose of this study is to see if either stopping anti-HIV drugs for short periods of time and/or adding a vaccine to the anti-HIV drugs being taken will help to better control HIV infection. The study will test whether these treatment approaches are safe. The HIV vaccine in this study has been tested in people who did not have HIV infection and improved the way their immune system worked. This study will evaluate whether these same immune system changes happen in people with HIV, and, if such changes do occur, assess whether these changes help to improve control of HIV in these patients.
Details: The best hope for long-term control of HIV infection in an individual likely rests with the resumption of effective HIV-specific immune responses. Intermittent antiretroviral therapy (ART) withdrawal, as an attempt to "immunize" the subject with his/her own active viral quasi-species population, represents an alternative approach to traditional immunization strategies. This study hopes to determine whether intermittent ART withdrawal serves to stimulate HIV-specific immune responses and control of viral replication. This approach will be compared with vaccination with ALVAC-HIV vCP1452. In addition, it is conceivable that intermittent ART withdrawal could boost and broaden the prime response to exogenous vaccine; that will also be studied. Patients will continue receiving their potent ART (not provided by the study) and will be randomly assigned to one of four treatment strategies as follows: Arm A: ALVAC placebo and potent ART for 92 weeks with a single 12- to 20-week therapy withdrawal period; Arm B: ALVAC placebo and potent ART for 84 weeks with a 4- to 6-week therapy withdrawal period, a 4-week therapy withdrawal period, and a 12- to 20-week therapy withdrawal period; Arm C: ALVAC vCP1452 vaccine and potent ART for 92 weeks with a single 12- to 20-week therapy withdrawal period; and Arm D: ALVAC vCP1452 vaccine and potent ART for 84 weeks with a 4- to 6-week therapy withdrawal period, a 4-week therapy withdrawal period, and a 12- to 20-week therapy withdrawal period. Immunizations of placebo or vaccine wil be administered in 3 separate sets of 3 injections per set (9 total) and immunization schedules are the same for all patients, those undergoing intermittent therapy withdrawal (Arms B and D) and those who are not (Arms A and C). This is a multiple-step study. Patients in Arms B and D will receive a 4-week period of potent ART therapy along with the first set of immunizations (Step 1) followed by therapy withdrawal for 4 to 6 weeks (Step 2). Alternating periods of therapy resumption (Step 3, consisting of 16 weeks on potent ART with the second set of vaccine administrations), a second therapy withdrawal (Step 4 for 4 weeks), and another therapy resumption (Step 5, consisting of 16 weeks on potent ART with the third set of vaccine administrations) will follow. Patients in Arms A and C will remain on Step 1 for the first 44 weeks on study. After 44 to 46 weeks on study, patients in all arms will have therapy withdrawn for 12 to 20 weeks (Step 6). Following completion of Step 6, patients whose viral load are below 10,000 copies/ml will be encouraged to remain off potent ART (Step 7) until completion of the study, as long as CD4 T-cell levels remain 50 percent or more of their baseline levels. Participants who successfully complete Step 7 will be invited to enter Step 9, a 48-week optional protocol extension. Otherwise, patients will restart their potent ART regimens (Step 8) and receive virologic and CD4 T-cell monitoring until completion of the study. All patients will be monitored at regular clinic visits. Viral load and CD4 T-cell counts will be measured at each visit. Patients in all arms may participate in substudy A5101s (Male Genital Secretions) or substudy A5137s (Female Genital Secretions), and patients in Arms B and D may participate in substudy A5111s (Latent Infected T-Cell Clearance).
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria for Step 1 - HIV infection - CD4 count greater than 400 cells/mm3 within 6 months before study entry - Current, persistent viral load below 400 copies/ml for 6 months before study entry and under 50 copies/ml at study screening - Currently receiving their first combination ART regimen (3 or more antiretrovirals) for at least 4 weeks before screening, or if the current potent ART regimen is not their first potent ART regimen, must have been receiving the current regimen for at least 4 weeks prior to screening - Negative pregnancy test within 45 days before study entry - Acceptable methods of contraception - Provide informed consent Exclusion Criteria - Immunomodulators within 45 days of study entry such as systemic corticosteroids, interferons, interleukins, thalidomide, sargramostim (granulocyte-macrophage colony-stimulating factor [GM-CSF]), dinitrochlorobenzene (DNCB), thymosin alpha, thymopentin, inosiplex, polyribonucleoside, and ditiocarb sodium - Abacavir within 8 weeks of study entry - Infection or medical illness within 14 days of study entry - Cancer that may require systemic therapy - History of lymph node radiation therapy - Prior HIV vaccine - Received hydroxyurea within 45 days of study entry - Close contact with canaries through work (e.g., breeding farms, bird shops); patients with a pet canary are not excluded - Abuse or dependence on drugs or alcohol - Allergic to albumin - Pregnant or breastfeeding - Infected with HIV within 1 year of study entry - Interruption of potent ART for more than 7 consecutive days within 1 year of study entry - History of allergy to egg proteins or neomycin - History of other serious acute allergic reactions (e.g., anaphylaxis, allergy-induced asthma, Stevens-Johnson syndrome, toxic epidermal necrolysis)
Total Enrollment: 100
Location and Contact Information:
Overall Study Official:
JeffreyJacobson, Study Chair, Beth Israel Medical Center
Beth Israel Med Ctr
New York City, New York, 10003
United States
Brown Univ / Miriam Hosp
Providence, Rhode Island, 02906
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Wishard Hosp
Indianapolis, Indiana, 46202
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Brigham and Women's Hosp
Boston, Massachusetts, 02215
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Univ of California San Francisco
San Francisco, California, 94110
United States
MetroHealth Med Ctr
Cleveland, Ohio, 441091998
United States
Community Health Network Inc
Rochester, New York, 14642
United States
Univ of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Univ of Washington
Seattle, Washington, 98104
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Univ of Texas, Southwestern Med Ctr of Dallas
Dallas, Texas, 75390
United States
Miriam Hosp / Brown Univ
Providence, Rhode Island, 02906
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Additional Information:
Study ID Numbers: ACTG A5068; Substudy AACTG A5101s,Substudy AACTG A5137s,Substudy AACTG A5111s,AACTG A5068
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00011011
Other Hiv Infections Studies:
1. Phase I Trial of an Intervention to Increase Condom Use by HIV-Discordant Couples
2. A Study of Physical and Metabolic Abnormalities in HIV Infected and Uninfected Children and Youth
3. Evaluation of Specific Infection-Fighting Cells For Prediction of Immune Response to Anti-HIV and Immune-Boosting Medication
4. A Study of Thymic Humoral Factor (THF gamma 2) in HIV-Infected Patients
5. A Study to Evaluate the Use of Memantine In Combination with Anti-HIV Drugs to Treat AIDS Dementia Complex (ADC)
Related Studies:
Other HIV Infections Clinical Trials
Other Rhode Island Clinical Trials
Other Providence Clinical Trials
Vaccine (ALVAC-HIV vCP1452) Use and Intermittent Withdrawal of Anti-HIV Drugs in Patients with HIV
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