A Comparison of Two Anti-HIV Treatment Plans

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00005915
First received: June 15, 2000
Last updated: September 28, 2013
Last verified: September 2013
  Purpose

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
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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 480
Study Completion Date: June 2004
Detailed Description:

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].

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Patients may be eligible if they:

  • Have proof of MDR virus from a blood test.
  • Have a viral load above 5,000 copies/ml from the same blood sample showing MDR virus.
  • Intend to start a new anti-HIV treatment around the time of the study.
  • Have been on a stable anti-HIV treatment between 14 days prior to the blood test mentioned above and when they are randomly assigned to a treatment.
  • Are at least 13 years old (consent of parent or guardian required if under 18).
  • (This protocol has been changed to reflect new criteria.)

Exclusion Criteria

Patients will not be eligible if they:

  • Have received a vaccine or had an illness that might affect viral load within 14 days before the blood test showing MDR virus.
  • Have received IL-2 within 4 months of the above-mentioned blood test or plan to take IL-2 during the study.
  • Have an opportunistic (AIDS-related) infection requiring treatment.
  • Are pregnant or breast-feeding.
  • Are currently participating in CPCRA 057 (PIP study).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005915

Locations
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, 80204
Univ Hosp Infectious Disease
Denver, Colorado, United States, 80204
United States, Connecticut
Yale U / New Haven Med Ctr / AIDS Clinical Trials Unit
New Haven, Connecticut, United States, 06510
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, 70112
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
Southern New Jersey AIDS Clinical Trials
Camden, New Jersey, United States, 08103
North Jersey Community Research Initiative
Newark, New Jersey, United States, 07103
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, 23298
Sponsors and Collaborators
Investigators
Study Chair: Jody Lawrence
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00005915     History of Changes
Other Study ID Numbers: CPCRA 064, 11619
Study First Received: June 15, 2000
Last Updated: September 28, 2013
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
HIV-1
Drug Administration Schedule
Drug Resistance, Microbial
Disease Progression
Genotype
Phenotype
Drug Resistance, Multiple
Anti-HIV Agents
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on August 21, 2014