A Study of Two Methods of Determining When to Begin or Change Anti-HIV Treatment

HIV Infections Clinical Trial

Official title:

A Randomized Study of the Clinical Effects of Initiating or Changing Antiretroviral Therapy Based on Plasma HIV RNA Quantitation Compared With Initiating or Changing Therapy Based on Current Clinical Practice Alone

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00001069
• Other study ID #: CPCRA 036
• Status: Terminated
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: January 2003
• 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

PRIMARY: To compare the clinical efficacy of two decision making strategies for initiating or changing antiretroviral therapy: decision making based on current clinical practice alone (i.e., initiating or changing therapy based on CD4 count decline and/or clinical progression) versus decision making based on plasma HIV RNA quantitation in addition to current clinical practice.

SECONDARY: To evaluate toxicity, biological markers, and patient management in the two arms.

Although changing therapies is a common strategy in the treatment of HIV disease, guidelines are needed to help clinicians and patients decide when a change in antiretroviral therapy is indicated. The technology of measuring HIV RNA in plasma has been suggested as a tool for monitoring clinical drug efficacy. However, uncertainty remains about whether aggressive antiretroviral treatment to lower HIV RNA and maintain low levels for as long as possible will confer clinical benefit in comparison with management based on monitoring CD4 counts and HIV-related symptoms.

Description:

Although changing therapies is a common strategy in the treatment of HIV disease, guidelines are needed to help clinicians and patients decide when a change in antiretroviral therapy is indicated. The technology of measuring HIV RNA in plasma has been suggested as a tool for monitoring clinical drug efficacy. However, uncertainty remains about whether aggressive antiretroviral treatment to lower HIV RNA and maintain low levels for as long as possible will confer clinical benefit in comparison with management based on monitoring CD4 counts and HIV-related symptoms.

Patients are randomized to a decision making strategy for initiating or changing therapy based on current clinical practice alone vs. decision making based on plasma HIV RNA quantitation in addition to current clinical practice in patients with <= 300 CD4+ cells/mm3. All patients in the RNA arm as well as a subset (n = 183) of those in the CCP arm will have a plasma HIV RNA quantitation drawn every 4 months. The results of these quantitations will be blinded until the end of the study. CD4 counts will be obtained at least every 4 months if the previous count was > 20 cells/mm3. The remaining patients in the CCP arm will have CD4 counts obtained according to their clinicians' current clinical practices. Medications, clinical status, and changes in antiretroviral therapy will be recorded for all patients in the study. Patients are stratified by CD4+ cell count (<100 cells/mm3 [200 patients] vs. 100-300 cells/mm3 [900 patients]).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1100
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

Inclusion Criteria

Patients must have:

• HIV infection.

• CD4 count <= 300 cells/mm3.

• NO stage 2 or worse AIDS dementia complex.

• Life expectancy of at least 6 months.

• Reasonably good health.

• age >= 13yrs.

• signed informed consent.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Disorders or conditions that may prevent adequate compliance with study requirements.

Patients with the following prior conditions are excluded:

• Stage 2 >= AIDS dementia complex.

Study Design

Observational Model: Natural History

Related Conditions & MeSH terms

• HIV Infections

Locations

Country	Name	City	State
United States	Partners Research	Albuquerque	New Mexico
United States	AIDS Research Consortium of Atlanta	Atlanta	Georgia
United States	Baltimore Trials	Baltimore	Maryland
United States	Southern New Jersey AIDS Cln Trials / Dept of Med	Camden	New Jersey
United States	AIDS Research Alliance - Chicago	Chicago	Illinois
United States	Denver CPCRA / Denver Public Hlth	Denver	Colorado
United States	Comprehensive AIDS Alliance of Detroit	Detroit	Michigan
United States	Henry Ford Hosp	Detroit	Michigan
United States	Louisiana Comm AIDS Rsch Prog / Tulane Univ Med	New Orleans	Louisiana
United States	Harlem AIDS Treatment Group / 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	Portland Veterans Adm Med Ctr / Rsch & Education Grp	Portland	Oregon
United States	The Research and Education Group	Portland	Oregon
United States	Richmond AIDS Consortium	Richmond	Virginia
United States	Community Consortium of San Francisco	San Francisco	California
United States	Veterans Administration Med Ctr / Regional AIDS Program	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 (3)

Doepel LK. Volunteers needed for study of HIV viral load test. NIAID AIDS Agenda. 1995 Dec:3. — View Citation

James JS. Viral load: new "strategy" trial in 15 U.S. cities. AIDS Treat News. 1995 Oct 20;(no 233):1-3. — View Citation

Raghavan S, Grant LB, Barisch G, Thompson M, Williams B, Matoe N, el-Sadr WM. Change in log10 HIV RNA and protease inhibitor use associated with weight change in HIV+ men in a national clinical trial. Int Conf AIDS. 1998;12:556 (abstract no 32180)