A Study to Find the Best Dosing Schedule for Delavirdine, Zidovudine, and Indinavir in HIV-Positive Patients
This study has been completed.
Sponsor:
Pharmacia and Upjohn
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002236
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 2000
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Purpose
The purpose of this study is to see whether it is better to take delavirdine (DLV) plus indinavir (IDV) plus zidovudine (ZDV) twice a day or three times a day.
| Condition | Intervention |
|---|---|
|
HIV Infections |
Drug: Indinavir sulfate Drug: Delavirdine mesylate Drug: Zidovudine |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label, Parallel Group, Pilot Study of Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of BID and TID Regimens of Delavirdine Mesylate, Zidovudine, and Indinavir Sulfate in HIV-1 Infected Individuals |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Sulfate ion
Zidovudine
Delavirdine mesylate
Indinavir
Indinavir sulfate
U.S. FDA Resources
Further study details as provided by NIH AIDS Clinical Trials Information Service:
| Estimated Enrollment: | 32 |
Patients are divided into 2 treatment groups; the groups are balanced with respect to viral load. Group A receives ZDV, DLV, and IDV 3 times daily. Group B receives ZDV, DLV, and IDV 2 times daily. Patients are evaluated for changes from baseline in viral load and CD4 cell count.
Eligibility| Ages Eligible for Study: | 14 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria
You may be eligible for this study if you:
- Are HIV-positive.
- Have a viral load (level of HIV in the blood) of at least 20,000 copies/ml.
- Have a CD4 cell count of at least 50 cells/mm3.
- Are at least 14 years old (consent of parent or guardian is required if under 18).
Exclusion Criteria
You will not be eligible for this study if you:
- Have ever taken an anti-HIV drug other than ZDV.
- Have taken ZDV for more than 1 month.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002236
Locations
| United States, California | |
| AIDS Healthcare Foundation | |
| Los Angeles, California, United States, 90027 | |
| UCSF AIDS Research Institute | |
| San Francisco, California, United States, 94105 | |
| United States, New York | |
| Saint Luke's - Roosevelt Hosp Ctr | |
| New York, New York, United States, 10019 | |
| United States, Pennsylvania | |
| Anderson Clinical Research | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Tennessee | |
| Univ of Tennessee / Div of Infect Dis / Dept of Med | |
| Memphis, Tennessee, United States, 38165 | |
| United States, Virginia | |
| Infectious Disease Physicians Inc | |
| Annandale, Virginia, United States, 22203 | |
Sponsors and Collaborators
Pharmacia and Upjohn
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00002236 History of Changes |
| Other Study ID Numbers: | 228G, M/3331/0072 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
|
Drug Therapy, Combination Zidovudine Drug Administration Schedule HIV Protease Inhibitors CD4 Lymphocyte Count |
Indinavir Delavirdine Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Zidovudine Reverse Transcriptase Inhibitors Delavirdine |
Indinavir HIV Protease Inhibitors Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents Protease Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013