A Randomized Trial of the Efficacy and Safety of a Strategy of Starting With Nelfinavir Versus Ritonavir Added to Background Antiretroviral (AR) Nucleoside Therapy in HIV-Infected Individuals With CD4+ Cell Counts Less Than or Equal to 200/mm3
Public ClinicalTrials.gov record NCT00000859. 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.
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Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
To compare nelfinavir (NFV) with ritonavir (RTV) for delaying disease progression or death in HIV-infected patients with CD4+ cell counts less than 100 cells/mm3 \[AS PER AMENDMENT 3/11/98: less than or equal to 200 cells/mm3\]. To compare NFV with RTV for the development of adverse events and for rates of permanent discontinuation of study medication. \[AS PER AMENDMENT 10/02/97: To compare by intention-to-treat analysis for disease progression, including death, the following two regimens: NFV plus background combination antiretroviral (AR) therapy followed by indinavir (IDV) or RTV in the event of significant intolerance; and RTV plus AR therapy followed by IDV, then NFV, in the event of significant intolerance.\] \[AS PER AMENDMENT 3/11/98: SUBSTUDY CPCRA 045: To determine the relative rates of emergence of HIV-1 resistance and to compare changes in plasma HIV RNA levels and CD4+ cell counts in a sample of patients with CD4+ cell counts \<= 200/mm3 who are enrolled in protocol CPCRA 042.\] AR therapy is rapidly becoming the standard of care for the treatment of HIV infection. AR therapy provides the best opportunity for maximizing viral suppression, reducing toxicity and delaying the emergence of resistant strains. The newest class of AR agents, the HIV protease inhibitors, exhibits the most potent anti-HIV effects described to date. This study will compare 2 protease inhibitors, NFV and RTV for efficacy and safety in a population with advanced HIV disease, who are taking various background nucleoside therapies.
Study identification
- NCT ID
- NCT00000859
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 1,300 participants
Conditions and interventions
Conditions
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
- Dec 2001 (Actual)
- Last update posted
- Oct 29, 2021
Ends 2001
United States locations
- U.S. sites
- 32
- U.S. states
- 14
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Community Consortium / UCSF | San Francisco | California | 94110 | — |
| Community Consortium of San Francisco | San Francisco | California | 94110 | — |
| Denver Community Program for Clinical Research on AIDS | Denver | Colorado | 80204 | — |
| Denver CPCRA / Denver Pub Hlth / Rocky Mt Cancer Ctr Aurora | Denver | Colorado | 80204 | — |
| Denver CPCRA / Denver Public Hlth | Denver | Colorado | 80204 | — |
| Infectious Disease Physicians / Northern Virginia | Washington D.C. | District of Columbia | 20422 | — |
| Timothy A Price | Washington D.C. | District of Columbia | 20422 | — |
| Veterans Administration Med Ctr / Regional AIDS Program | Washington D.C. | District of Columbia | 20422 | — |
| Washington Reg AIDS Prog / Dept of Infect Dis | 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 | — |
| Louisiana Community AIDS Research Program | New Orleans | Louisiana | 70112 | — |
| Baltimore TRIALS | Baltimore | Maryland | 21201 | — |
| Westat / NICHD | Rockville | Maryland | 20850 | — |
| Comprehensive AIDS Alliance of Detroit | Detroit | Michigan | 48201 | — |
| Wayne State Univ / Univ Hlth Ctr | Detroit | Michigan | 48201 | — |
| Henry Ford Hosp | Detroit | Michigan | 48202 | — |
| Mercer Area Early Intervention Services | Camden | New Jersey | 08103 | — |
| Southern New Jersey AIDS Clinical Trials | Camden | New Jersey | 08103 | — |
| Southern New Jersey AIDS Cln Trials / Dept of Med | Camden | New Jersey | 08103 | — |
| New Jersey Community Research Initiative | Newark | New Jersey | 07103 | — |
| North Jersey Community Research Initiative | Newark | New Jersey | 07103 | — |
| Partners in Research - New Mexico | Albuquerque | New Mexico | 87131 | — |
| Partners Research | Albuquerque | New Mexico | 87131 | — |
| Harlem AIDS Treatment Group / Harlem Hosp Ctr | New York | New York | 10037 | — |
| Harlem AIDS Treatment Group | New York | New York | 10037 | — |
| Portland Veterans Adm Med Ctr / Rsch & Education Grp | Portland | Oregon | 97210 | — |
| The Research and Education Group | Portland | Oregon | 97210 | — |
| Philadelphia FIGHT | Philadelphia | Pennsylvania | 19107 | — |
| Saint Joseph's Hosp | 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.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 12 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00000859, 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 Oct 29, 2021 · Synced Nov 7, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00000859 live on ClinicalTrials.gov.