A Comparison of Two Anti-HIV Treatment Plans
- Conditions
- HIV Infections
- Registration Number
- NCT00005915
- Brief Summary
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.
- 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 \[AS PER AMENDMENT 07/03/01: Plasma Point Mutation Substudy and PBMC Point Mutation Substudy\].
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 480
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (21)
Yale U / New Haven Med Ctr / AIDS Clinical Trials Unit
🇺🇸New Haven, Connecticut, United States
Washington Reg AIDS Prog / Dept of Infect Dis
🇺🇸Washington, District of Columbia, United States
Wayne State Univ - WSU/DMC / Univ Hlth Ctr
🇺🇸Detroit, Michigan, United States
Southern New Jersey AIDS Clinical Trials
🇺🇸Camden, New Jersey, United States
The Research and Education Group
🇺🇸Portland, Oregon, United States
Community Consortium / UCSF
🇺🇸San Francisco, California, United States
Lawrence Goldyn, MD
🇺🇸San francisco, California, United States
AIDS Research Alliance - Chicago
🇺🇸Chicago, Illinois, United States
North Jersey Community Research Initiative
🇺🇸Newark, New Jersey, United States
Philadelphia FIGHT
🇺🇸Philadelphia, Pennsylvania, United States
Montrose Clinic
🇺🇸Houston, Texas, United States
Univ TX Health Science Ctr
🇺🇸Houston, Texas, United States
Univ Hosp Infectious Disease
🇺🇸Denver, Colorado, United States
Houston Veterans Administration Med Ctr
🇺🇸Houston, Texas, United States
Denver CPCRA / Denver Public Hlth
🇺🇸Denver, Colorado, United States
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
🇺🇸New Orleans, Louisiana, United States
Harlem AIDS Treatment Grp / Harlem Hosp Ctr
🇺🇸New York, New York, United States
Richmond AIDS Consortium / Div of Infect Diseases
🇺🇸Richmond, Virginia, United States
Henry Ford Hosp
🇺🇸Detroit, Michigan, United States
Our Lady of the Lake Regional Med Ctr
🇺🇸New Orleans, Louisiana, United States
Bronx-Lebanon Hosp Ctr
🇺🇸Bronx, New York, United States