The Safety and Effectiveness of Adefovir Dipivoxil Plus Indinavir Combined With Zidovudine or Lamivudine or Stavudine in HIV-Infected Patients Who Have Not Taken Anti-HIV Drugs
Public ClinicalTrials.gov record NCT00002379. 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, Stratified, Randomized, Open-Label, Multi-Center Study of the Safety and Efficacy of Adefovir Dipivoxil and Indinavir in Combination With Zidovudine, Lamivudine, or Stavudine for the Treatment of Therapy Naive HIV-Infected Patients With CD4 Cell Counts >= 100 Cells/mm3 and HIV-1 RNA Copy Numbers >= 5,000 Copies/Ml
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
To evaluate the safety and tolerance of adefovir dipivoxil and indinavir administered orally in combination with zidovudine, lamivudine, or stavudine in HIV-infected patients with CD4 cell counts \>= 100 cells/mm3 and an HIV-1 RNA baseline copy number \>= 5000 copies/ml. To determine the proportion of patients whose plasma HIV-1 RNA level falls below the level of detection (500 copies/ml) by 20 weeks of study therapy and the average reduction in HIV-1 RNA from baseline through study week 20. To evaluate the durability of the antiviral response through 48 weeks of study in patients who continue on study therapy after week 24.
Study identification
- NCT ID
- NCT00002379
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 100 participants
Conditions and interventions
Conditions
Interventions
- Indinavir sulfate Drug
- Levocarnitine Drug
- Adefovir dipivoxil Drug
- Lamivudine Drug
- Stavudine Drug
- Zidovudine Drug
Drug
Eligibility (public fields only)
- Age range
- 16 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
- 14
- U.S. states
- 12
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Phoenix Body Positive | Phoenix | Arizona | 85016 | — |
| AIDS Healthcare Foundation Labs | Los Angeles | California | 90027 | — |
| Davies Med Ctr | San Francisco | California | 94114 | — |
| Blick Med Associates | Greenwich | Connecticut | 06830 | — |
| George Washington Med Ctr | Washington D.C. | District of Columbia | 20037 | — |
| Cook County Gen Hosp / Division of Infect Diseases | Chicago | Illinois | 60612 | — |
| Johns Hopkins Univ School of Medicine | Baltimore | Maryland | 21287 | — |
| Community Research Initiative | Brookline | Massachusetts | 02445 | — |
| Community Research Initiative on AIDS | New York | New York | 10001 | — |
| Saint Vincent's AIDS Ctr | New York | New York | 10011 | — |
| Hershey Med Ctr / Dept of Hematology | Hershey | Pennsylvania | 17033 | — |
| Mem Hosp of Rhode Island | Pawtucket | Rhode Island | 02860 | — |
| Univ of Texas Southwestern Med Ctr of Dallas | Dallas | Texas | 75235 | — |
| Swedish Med Ctr | Seattle | Washington | 98122 | — |
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 NCT00002379, 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 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00002379 live on ClinicalTrials.gov.