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Home > "E" Clinical Trials Conditions > Effectiveness of Giving an HIV Vaccine (Remune) to HIV-Positive Patients Receiving an Anti-HIV Drug Combination  Effectiveness of Giving an HIV Vaccine (Remune) to HIV-Positive Patients Receiving an Anti-HIV Drug Combination
Effectiveness of Giving an HIV Vaccine (Remune) to HIV-Positive Patients Receiving an Anti-HIV Drug Combination
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to look at the effects of the HIV vaccine Remune on viral load (level of HIV in the blood) and on the way the immune system responds to HIV. This study will also try to see if the effects of the vaccine are different in patients entering the study with a viral load below 50 copies/ml compared to those who have a viral load from 50 to 500 copies/ml. (This study is currently being redesigned and the purpose may be revised.) Treatment with anti-HIV drugs does not always keep HIV viral load undetectable (so low that it cannot be measured). This study originally added an HIV vaccine called Remune to treat patients. Remune was thought to reduce viral load and improve immune responses. However, new information suggests that Remune may not be as effective as was first believed. The study has been changed to follow people already in the study and to let people enroll only if they participate in the substudy. The substudy will look at the effect of another HIV vaccine, vCP1452, on the immune response and how it works in combination with Remune. Information about the safety of these vaccines in HIV-positive patients will be gathered.
Details: Studies have shown that inactivated, gp120-depleted whole virus immunogen (Remune) boosts immune responses to HIV. One response, lymphocyte proliferative response (LPR) to p24, is correlated with a low viral load in some patients with long-term non-progression of disease. This study examines whether administering Remune vaccine may generate new immune responses or boost existing responses to keep the level of virus in the blood low for a longer period of time than antiretroviral therapy alone. [AS PER AMENDMENT 7/20/00: In a recent study using Remune, comparison of virologic failure and time to virologic failure between Remune and adjuvant placebo arms revealed no differences between the 2 arms of the study. Results of this study suggest that the hypothesis in A5057 (that recipients of Remune would have only 50 percent of the number of virologic relapses as occur in the control arm) is no longer plausible in its current design. This protocol is being redesigned.] A substudy adds the HIV canarypox vaccine (vCP1452) in patients in the parent study and evaluates whether canarypox vaccine can augment the immune responses of Remune. Patients will add either Remune (Arm A), or the placebo Incomplete Freund's Adjuvant (Arm B), to their antiretroviral therapy. They will be stratified to 1 of the following 4 groups: (1) Patients suppressed with 3 or more antiretroviral drugs for 15 months or longer, with an HIV-1 RNA below 50 copies/ml, and who may have substituted 1 antiretroviral medication during that time. (2) Patients suppressed with 3 or more antiretroviral drugs, who have not taken antiretroviral medications for 15 months or longer, with an HIV-1 RNA below 50 copies/ml, and who may have substituted 1 antiretroviral medication during that time. [AS PER AMENDMENT 7/20/00: This stratum includes patients who have taken their current antiretroviral therapy for less than 15 months prior to screening viral load measurement. If these patients changed from prior antiretroviral regimen(s) during the 15 months prior to screening, they must have changed at least 2 antiretroviral drugs during this time.] (3) Patients suppressed with 3 or more antiretroviral drugs and whose HIV-1 RNA is 50 copies/ml or higher. (4) Patients suppressed with 2 antiretroviral drugs. Injections of either Remune or IFA are given at Day 1 and once every 12 weeks for 96 weeks. Patients remain at the clinic for observation for 30 minutes following the first and second injections. If a patient's HIV viral level rises above a certain level, the patient and his/her health care provider may decide to change antiretroviral drugs to try and lower it. Injections will be suspended until the lower level is achieved, then resumed on the regular 12-week schedule. If the decision is not to change therapy, or the viral load does not decrease to under 500 copies/ml within 3 to 4 months, injections may still be received as long as the HIV RNA level is below 5,000 copies/ml. Blood samples are collected prior to every injection to determine CD4/CD8 counts and viral load, to assay for viral presence in peripheral blood mononuclear cells, and to store for future studies. Pregnancy tests for women of reproductive potential, physical exams, and medical histories are done prior to every immunization. An immunological substudy will randomize 80 of the eligible volunteers from the study cohort to additionally receive ALVAC vCP1452 or placebo (ALVAC) with equal probability. Arm A will receive ALVAC vCP1452; Arm B will be administered placebo. [AS PER AMENDMENT 7/20/00: The study is closed to accrual except for patients who enroll into A5058s until the protocol can be redesigned. Patients enrolled under Version 1.0 continue to be followed every 12 weeks (plus or minus 14 days) until the end of the study. Patients should continue taking the same potent antiretroviral treatment that they were taking at study entry until reaching the primary endpoint of first virologic relapse.]
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 14 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Are HIV-positive. - Have been on certain anti-HIV drugs for at least 3 months and intend to continue the same anti-HIV drugs unless they develop side effects to the drugs or their viral load rises above a certain level. - Have a viral load of less than 500 copies/ml for at least 3 months before entering the study. - Have a CD4 count of at least 300 cells/mm3. - Are at least 14 years old (consent of parent or guardian required if under 18). - Agree to practice barrier methods of birth control (such as condoms) while on the study and for 3 months after the study ends. - Patients may be eligible for the substudy if they: - Are at least 18 years old. - Have a plasma HIV viral load below 50 copies/ml. Exclusion Criteria Patients will not be eligible for this study if they: - Are pregnant or breast-feeding. - Have had an infection requiring antibiotics, an outbreak of herpes simplex virus (HSV) or herpes zoster, or other illness or surgery within 30 days of study entry. (This study has been changed to exclude patients who have had an outbreak of HSV or herpes zoster or have had surgery within 30 days of study entry.) - Currently have any long-term infection other than HIV. - Have cancer that requires chemotherapy. - Have had lymph node irradiation. - Have ever received an HIV vaccine. - Have taken certain drugs affecting the immune system within 30 days of study entry. - Have taken hydroxyurea within 30 days of study entry. - Have received any vaccine within 30 days of study entry. - Patients will not be eligible for the substudy if they: - Have a history of allergies to egg proteins or neomycin, or a history of other serious allergic reactions. - Ever worked closely with canaries in a bird shop or breeding farm.
Total Enrollment: 472
Location and Contact Information:
Overall Study Official:
FredValentine, Study Chair,
Univ of Hawaii
Honolulu, Hawaii, 96816
United States
MetroHealth Med Ctr
Cleveland, Ohio, 441091998
United States
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 37203
United States
Wishard Hosp
Indianapolis, Indiana, 46202
United States
Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
San Francisco Gen Hosp
San Francisco, California, 941102859
United States
St Mary's Hosp (Univ of Rochester/Infectious Diseases)
Rochester, New York, 14642
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
Denver Dept of Health and Hosps
Denver, Colorado, 80262
United States
Marin County Specialty Clinic
San Rafael, California, 94903
United States
Harbor UCLA Med Ctr
Torrance, California, 90502
United States
Chelsea Ctr
New York City, New York, 10021
United States
Stanford Univ Med Ctr
Stanford, California, 943055107
United States
Community Health Network Inc
Rochester, New York, 14642
United States
San Mateo AIDS Program / Stanford Univ
Stanford, California, 943055107
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
Boston Med Ctr
Boston, Massachusetts, 02118
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Univ of Washington
Seattle, Washington, 98104
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Univ of Texas Galveston
Galveston, Texas, 775550435
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Univ of Minnesota
Minneapolis, Minnesota, 55455
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Univ of Puerto Rico
San Juan, , 009365067
Puerto Rico
Cornell Univ Med Ctr
New York City, New York, 10021
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202
United States
Willow Clinic
Menlo Park, California, 94025
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
Philadelphia Veterans Administration Med Ctr
Philadelphia, Pennsylvania, 19104
United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Moses H Cone Memorial Hosp
Greensboro, North Carolina, 27401
United States
Brigham and Women's Hosp
Boston, Massachusetts, 02215
United States
Additional Information:
Study ID Numbers: ACTG A5057; AACTG A5057,A5058s
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005758
Other Hiv Infections Studies:
1. A Study of Ritonavir (an Anti-HIV Drug) in HIV-Positive Infants and Children
2. A Phase I Study of Combination Therapy With Didanosine (ddI) and Ribavirin in HIV-Infected Children.
3. An Open-Label, Pilot Study to Evaluate the Development of Resistance to Nevirapine (BI-RG-587) in HIV-Infected Patients With CD4 Cell Count >= 500/mm3
4. Randomized Comparative Study of Fluconazole Versus Clotrimazole Troches in the Prevention of Serious Fungal Infection in Patients With AIDS or Advanced AIDS-Related Complex. (A Nested Study of ACTG 081)
5. Blood Vessel Function in HIV-Infected Patients Taking Anti-HIV Drugs
Related Studies:
Other HIV Infections Clinical Trials
Other Pennsylvania Clinical Trials
Other Pittsburgh Clinical Trials
Effectiveness of Giving an HIV Vaccine (Remune) to HIV-Positive Patients Receiving an Anti-HIV Drug Combination
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