A Comparison of Epivir Plus Crixivan Combined With Zerit or Retrovir in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs - Tabular View

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A Comparison of Epivir Plus Crixivan Combined With Zerit or Retrovir in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

This study has been completed.

Study NCT00002369. Last updated on October 1, 2007. Information provided by Bristol-Myers Squibb

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	A Comparison of Epivir Plus Crixivan Combined With Zerit or Retrovir in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
Official Title ^†	An Open Label, Randomized, Comparative Study of Zerit (d4T) + Epivir (3TC) + Crixivan Versus Retrovir (AZT) + Epivir (3TC) + Crixivan in HIV-Infected, Antiretroviral Naive Subjects With CD4 Cell Counts of 200 - 700 Cells/mm3 and HIV RNA Baseline Copy Number of >= 10,000 Copies/ml
Brief Summary	To evaluate the tolerance, and comparative virologic and immunologic effects of the two combination regimens.
Detailed Description	100 patients will be randomized to receive Zerit (Stavudine) + Epivir (Lamivudine) + Crixivan (Indinavir) and 100 patients will be randomized to receive Retrovir (Zidovudine) + Epivir (Lamivudine) + Crixivan (Indinavir). Patients will be treated for 48 weeks.
Study Phase
Study Type ^†	Interventional
Study Design ^†	Treatment, Parallel Assignment, Safety Study
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	HIV Infections
Intervention ^†	Drug: Indinavir sulfate Drug: Lamivudine Drug: Stavudine Drug: Zidovudine
MEDLINE PMIDs
Links	BMS Clinical Trials Disclosure For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm

Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†	200
Start Date ^†
Completion Date
Eligibility Criteria ^†	Inclusion Criteria Patients must have: Documented HIV infection. CD4 cell count of 200 - 700 cells/mm3. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: AIDS defining condition within 1 month of study entry. Prior Medication: Excluded: Patients with any history of antiretroviral therapy treatment.
Gender	Both
Ages	16 Years and older
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States, Puerto Rico

Administrative Information Fields
NCT ID ^†	NCT00002369
Organization ID	260A
Secondary IDs ^††	BMS 001
Study Sponsor ^†	Bristol-Myers Squibb
Collaborators ^††
Investigators ^†
Information Provided By	Bristol-Myers Squibb
Verification Date	October 2007
First Received Date ^†	November 2, 1999
Last Updated Date	October 1, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.