A Comparison of Two Anti-HIV Treatment Plans

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005915
• Other study ID #: CPCRA 064
• Secondary ID: 11619
• Status: Completed
• Phase: N/A
• First received: June 15, 2000
• Last updated: September 28, 2013
• Est. completion date: June 2004

Study information

• Verified date: September 2013
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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).

Study Design

N/A

Related Conditions & MeSH terms

• HIV Infections

Locations

Country	Name	City	State
United States	Bronx-Lebanon Hosp Ctr	Bronx	New York
United States	Southern New Jersey AIDS Clinical Trials	Camden	New Jersey
United States	AIDS Research Alliance - Chicago	Chicago	Illinois
United States	Denver CPCRA / Denver Public Hlth	Denver	Colorado
United States	Univ Hosp Infectious Disease	Denver	Colorado
United States	Henry Ford Hosp	Detroit	Michigan
United States	Wayne State Univ - WSU/DMC / Univ Hlth Ctr	Detroit	Michigan
United States	Houston Veterans Administration Med Ctr	Houston	Texas
United States	Montrose Clinic	Houston	Texas
United States	Univ TX Health Science Ctr	Houston	Texas
United States	Yale U / New Haven Med Ctr / AIDS Clinical Trials Unit	New Haven	Connecticut
United States	Louisiana Comm AIDS Rsch Prog / Tulane Univ Med	New Orleans	Louisiana
United States	Our Lady of the Lake Regional Med Ctr	New Orleans	Louisiana
United States	Harlem AIDS Treatment Grp / Harlem Hosp Ctr	New York	New York
United States	North Jersey Community Research Initiative	Newark	New Jersey
United States	Philadelphia FIGHT	Philadelphia	Pennsylvania
United States	The Research and Education Group	Portland	Oregon
United States	Richmond AIDS Consortium / Div of Infect Diseases	Richmond	Virginia
United States	Community Consortium / UCSF	San Francisco	California
United States	Lawrence Goldyn, MD	San francisco	California
United States	Washington Reg AIDS Prog / Dept of Infect Dis	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (4)

Anti-HIV agents. An attempt at treatment interruption--trial CPCRA 064. TreatmentUpdate. 2003 Aug-Sep;15(5):4-5. — View Citation

Lawrence J, Hullsiek KH, Thackeray LM, Abrams DI, Crane LR, Mayers DL, Jones MC, Saldanha JM, Schmetter BS, Baxter JD. Disadvantages of structured treatment interruption persist in patients with multidrug-resistant HIV-1: final results of the CPCRA 064 st — View Citation

Lawrence J, Mayers DL, Hullsiek KH, Collins G, Abrams DI, Reisler RB, Crane LR, Schmetter BS, Dionne TJ, Saldanha JM, Jones MC, Baxter JD; 064 Study Team of the Terry Beirn Community Programs for Clinical Research on AIDS. Structured treatment interruption in patients with multidrug-resistant human immunodeficiency virus. N Engl J Med. 2003 Aug 28;349(9):837-46. — View Citation

Paquet AC, Baxter J, Weidler J, Lie Y, Lawrence J, Kim R, Bates M, Coakley E, Chappey C. Differences in reversion of resistance mutations to wild-type under structured treatment interruption and related increase in replication capacity. PLoS One. 2011 Jan — View Citation

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