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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00005915 |
The purpose of this study is to compare 2 treatment plans to try to increase the effects of anti-HIV drugs in patients who are resistant to the drug effects.
Sometimes the increase in a patient's viral load (the level of HIV in the blood) can be slowed or stopped by taking anti-HIV drugs. This does not always happen. Sometimes anti-HIV drugs work at first but then stop working. When most of the usual anti-HIV drugs no longer seem to work, the virus is called multidrug-resistant (MDR). This study will compare 2 treatment plans to try to increase the effects of anti-HIV drugs in patients with MDR virus.
Condition |
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HIV Infections |
Study Type: | Observational |
Official Title: | A Randomized Study of a Prescribed 4-Month Structured Treatment Interruption (STI) Followed by Initiation of a New Antiretroviral Regimen Versus Immediate Initiation of a New Antiretroviral Regimen in HIV-Infected Patients With Multidrug Resistant (MDR) Virus |
Estimated Enrollment: | 480 |
An increasing number of patients are developing multidrug-resistant (MDR) virus, as determined by genotypic antiretroviral resistance testing (GART), due to treatment failure to suppress viral replication after several rounds of combination antiretroviral therapy. The best therapeutic strategy for these patients is uncertain. Two strategies currently being used are (1) STI followed by a new antiretroviral regimen and (2) immediate initiation of a new antiretroviral regimen.
Patients are screened for the presence of MDR virus and a plasma HIV RNA level greater than 10,000 [AS PER AMENDMENT 07/03/01: greater than 5,000] copies/ml. Eligible patients attend a baseline visit [AS PER AMENDMENT 07/03/01: and a subsequent randomization visit] where the qualifying GART results are provided. Patients who consent to participate have phenotypic antiretroviral resistance testing (PART) done on a specimen from the same blood draw that was used for the GART evaluation. After PART results are available, patients are randomized [AS PER AMENDMENT 07/03/01: If the predicted sensitivities are not available for some or all drugs included in the PART, the patient may still be randomized.] to either a 4-month STI followed by a new antiretroviral regimen or an immediate new antiretroviral regimen. The antiretroviral regimens chosen are based on the patients' history and both GART and PART results. [AS PER AMENDMENT 07/03/01: Additional GART and PART may be requested after at least 4 months of antiretroviral treatment.] Patients have the follow-up data collection done at Months 1-8 and every 4 months thereafter. Changes in antiretroviral therapy, Grade 4 adverse experiences, progression of disease, and deaths are reported as they occur. Patients are seen for clinical management as often as deemed necessary. All patients are followed to a common closing date estimated to be 24 months after the last patient is randomized. Some patients may participate in a Point Mutation Substudy [AS PER AMENDMENT 07/03/01: Plasma Point Mutation Substudy and PBMC Point Mutation Substudy].
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible if they:
Exclusion Criteria
Patients will not be eligible if they:
United States, California | |
Community Consortium / UCSF | |
San Francisco, California, United States, 94110 | |
Lawrence Goldyn, MD | |
San francisco, California, United States, 94110 | |
United States, Colorado | |
Denver CPCRA / Denver Public Hlth | |
Denver, Colorado, United States, 802044507 | |
Univ Hosp Infectious Disease | |
Denver, Colorado, United States, 802044507 | |
United States, Connecticut | |
Yale U / New Haven Med Ctr / AIDS Clinical Trials Unit | |
New Haven, Connecticut, United States, 065102483 | |
United States, District of Columbia | |
Washington Reg AIDS Prog / Dept of Infect Dis | |
Washington, District of Columbia, United States, 20422 | |
United States, Illinois | |
AIDS Research Alliance - Chicago | |
Chicago, Illinois, United States, 60657 | |
United States, Louisiana | |
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med | |
New Orleans, Louisiana, United States, 70112 | |
Our Lady of the Lake Regional Med Ctr | |
New Orleans, Louisiana, United States, 701122699 | |
United States, Michigan | |
Henry Ford Hosp | |
Detroit, Michigan, United States, 48202 | |
Wayne State Univ - WSU/DMC / Univ Hlth Ctr | |
Detroit, Michigan, United States, 48201 | |
United States, New Jersey | |
North Jersey Community Research Initiative | |
Newark, New Jersey, United States, 071032842 | |
Southern New Jersey AIDS Clinical Trials | |
Camden, New Jersey, United States, 08103 | |
United States, New York | |
Bronx-Lebanon Hosp Ctr | |
Bronx, New York, United States, 10453 | |
Harlem AIDS Treatment Grp / Harlem Hosp Ctr | |
New York, New York, United States, 10037 | |
United States, Oregon | |
The Research and Education Group | |
Portland, Oregon, United States, 97210 | |
United States, Pennsylvania | |
Philadelphia FIGHT | |
Philadelphia, Pennsylvania, United States, 19107 | |
United States, Texas | |
Houston Veterans Administration Med Ctr | |
Houston, Texas, United States, 77030 | |
Univ TX Health Science Ctr | |
Houston, Texas, United States, 77030 | |
Montrose Clinic | |
Houston, Texas, United States, 77006 | |
United States, Virginia | |
Richmond AIDS Consortium / Div of Infect Diseases | |
Richmond, Virginia, United States, 232980049 |
Study Chair: | Jody Lawrence |
Study ID Numbers: | CPCRA 064 |
Study First Received: | June 15, 2000 |
Last Updated: | August 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00005915 |
Health Authority: | United States: Federal Government |
HIV-1 Drug Administration Schedule Drug Resistance, Microbial Disease Progression Genotype |
Phenotype Drug Resistance, Multiple Anti-HIV Agents Treatment Experienced |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Disease Progression Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |