A Comparison of Nelfinavir Plus Saquinavir Plus Delavirdine or 3TC/ZDV Versus Nelfinavir Plus 3TC/ZDV in HIV-Infected Patients
Public ClinicalTrials.gov record NCT00001094. 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 Phase II, Randomized, Controlled, Open-Label Trial of Combination Therapy With Nelfinavir (NFV) and Saquinavir (SQV)Sgc With Delavirdine (DLV) or 3TC/ZDV Versus Nelfinavir (NFV) and 3TC/ZDV in Subjects With HIV Infection and > 5,000 HIV RNA Copies/ML
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
To compare the long-term virologic response to combination therapy with two protease inhibitors, i.e., nelfinavir (NFV) + saquinavir soft gel capsule (SQVsgc) and delavirdine (DLV) or combination lamivudine/zidovudine (3TC/ZDV, Combivir) versus NFV and 3TC/ZDV, in the proportion of patients demonstrating virologic success (\< 500 copies/ml HIV RNA) at week 48, without prior virologic or clinical failure. To evaluate the safety and tolerance of combination protease inhibitors. To evaluate the durability of virologic response as assessed by the Roche Ultra Sensitive assay (\< 200 copies/ml) and culturable virus. To compare time to a confirmed virologic response (two consecutive plasma HIV RNA levels \< 500 copies/ml) or to a confirmed treatment relapse following a confirmed virologic response across the treatment arms. To evaluate biologic phenotype (non-syncytium inducing versus syncytium inducing capacity) and the evolution and patterns of viral resistance among patients with confirmed treatment failures at or after weeks 16 to 24. To compare immunologic benefits, as measured by longitudinal CD4/CD8 cell count profiles. To evaluate the influence of baseline virologic and immunologic parameters on the magnitude and duration of plasma HIV RNA response. To compare virologic response between the two dose schedules of NFV and SQVsgc (bid vs tid) and between NFV and SQVsgc with either DLV or combination 3TC/ZDV. To evaluate compliance and exploratory population pharmacometrics. Past studies have shown that combination therapies not only will result in better clinical outcomes but may prolong the effects of therapy. The enhanced effects seen with combination therapies are likely related to a greater suppression of HIV replication and alterations in resistance patterns. Both in vitro and in vivo studies suggest that triple-drug therapy may have an advantage over one- and two-drug regimens. Therefore, triple-drug therapy appears to be an important strategy in the treatment of HIV infection.
Study identification
- NCT ID
- NCT00001094
- Recruitment status
- Withdrawn
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- Not listed
Conditions and interventions
Conditions
Interventions
- Lamivudine/Zidovudine Drug
- Nelfinavir mesylate Drug
- Saquinavir Drug
- Delavirdine mesylate Drug
Drug
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
- Mar 8, 2015
United States locations
- U.S. sites
- 16
- U.S. states
- 11
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Willow Clinic | Menlo Park | California | 94025 | — |
| Stanford Univ Med Ctr | Stanford | California | 943055107 | — |
| Univ of Colorado Health Sciences Ctr | Denver | Colorado | 80262 | — |
| Univ of Miami School of Medicine | Miami | Florida | 331361013 | — |
| Emory Univ | Atlanta | Georgia | 30308 | — |
| Queens Med Ctr | Honolulu | Hawaii | 96816 | — |
| Univ of Hawaii | Honolulu | Hawaii | 96816 | — |
| Louis A Weiss Memorial Hosp | Chicago | Illinois | 60640 | — |
| Tulane Univ School of Medicine | New Orleans | Louisiana | 70112 | — |
| SUNY / Erie County Med Ctr at Buffalo | Buffalo | New York | 14215 | — |
| Bellevue Hosp / New York Univ Med Ctr | New York | New York | 10016 | — |
| Carolinas Med Ctr | Charlotte | North Carolina | 28203 | — |
| Moses H Cone Memorial Hosp | Greensboro | North Carolina | 27401 | — |
| Univ of Cincinnati | Cincinnati | Ohio | 452670405 | — |
| Ohio State Univ Hosp Clinic | Columbus | Ohio | 432101228 | — |
| Univ of Texas Galveston | Galveston | Texas | 775550435 | — |
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 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00001094, 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 Mar 8, 2015 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00001094 live on ClinicalTrials.gov.