A Study of Two Methods of Determining When to Begin or Change Anti-HIV Treatment
Public ClinicalTrials.gov record NCT00001069. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00001069
- Recruitment status
- Terminated
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 1,100 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 13 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Not listed
- Primary completion
- Not listed
- Completion
- Not listed
- Last update posted
- Jun 23, 2005
United States locations
- U.S. sites
- 17
- U.S. states
- 14
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Community Consortium of San Francisco | San Francisco | California | 94110 | — |
| Denver CPCRA / Denver Public Hlth | Denver | Colorado | 802044507 | — |
| Veterans Administration Med Ctr / Regional AIDS Program | Washington D.C. | District of Columbia | 20422 | — |
| AIDS Research Consortium of Atlanta | Atlanta | Georgia | 30308 | — |
| AIDS Research Alliance - Chicago | Chicago | Illinois | 60657 | — |
| Louisiana Comm AIDS Rsch Prog / Tulane Univ Med | New Orleans | Louisiana | 70112 | — |
| Baltimore Trials | Baltimore | Maryland | 21201 | — |
| Comprehensive AIDS Alliance of Detroit | Detroit | Michigan | 48201 | — |
| Henry Ford Hosp | Detroit | Michigan | 48202 | — |
| Southern New Jersey AIDS Cln Trials / Dept of Med | Camden | New Jersey | 08103 | — |
| North Jersey Community Research Initiative | Newark | New Jersey | 071032842 | — |
| Partners Research | Albuquerque | New Mexico | 871315271 | — |
| Harlem AIDS Treatment Group / Harlem Hosp Ctr | New York | New York | 10037 | — |
| Portland Veterans Adm Med Ctr / Rsch & Education Grp | Portland | Oregon | 972109951 | — |
| The Research and Education Group | Portland | Oregon | 97210 | — |
| Philadelphia FIGHT | Philadelphia | Pennsylvania | 19107 | — |
| Richmond AIDS Consortium | Richmond | Virginia | 23298 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00001069, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 23, 2005 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00001069 live on ClinicalTrials.gov.