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A Study to Find the Best Dosing Schedule for Delavirdine, Zidovudine, and Indinavir in HIV-Positive Patients

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00002236
Enrollment
32
Registered
2001-08-31
Start date
Unknown
Completion date
Unknown
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Drug Therapy, Combination, Zidovudine, Drug Administration Schedule, HIV Protease Inhibitors, CD4 Lymphocyte Count, Indinavir, Delavirdine, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load

Brief summary

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.

Detailed description

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.

Interventions

DRUGIndinavir sulfate
DRUGZidovudine

Sponsors

Pharmacia and Upjohn
Lead SponsorINDUSTRY

Study design

Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026