Washington, District of Columbia 20007

  • HIV Infections

Purpose:

The purpose of this study is to see if L-756423, an anti-HIV drug, is safe to give with indinavir and if it works well at lowering the level of HIV in the blood (viral load).


Study summary:

All patients receive L-756423 plus indinavir plus two licensed nucleoside reverse transcriptase inhibitors (NRTIs), at least one to which the patient is naive. Patients remain on the drug regimen for 12 weeks (with possible extension to 16 weeks). Patients are evaluated with physical examinations and laboratory tests for blood and urine at Weeks 1, 2, 4, 6, 8, and 12 and two weeks post study. Plasma viral RNA is measured at Weeks 1, 2, 4, 6, 8, and 12. CD4 cell counts are measured at Weeks 2,4,8, and 12.


Criteria:

Inclusion Criteria You may be eligible for this study if you: - Are HIV-positive. - Are at least 18 years old. - Have a viral load of at least 1,000 copies/ml. - Have a CD4 cell count of at least 100 cells/mm3. - Have experienced treatment failure (your viral load increased significantly) within 24 weeks of study entry while taking indinavir. Exclusion Criteria You will not be eligible for this study if you: - Are taking nonnucleoside reverse transcriptase inhibitors (NNRTIs).


Study is Available At:


Original ID:

300A


NCT ID:

NCT00002452


Secondary ID:

008-00


Study Acronym:


Brief Title:

A Study on the Safety and Effectiveness of L-756423 Plus Indinavir in HIV-Positive Patients Who Have Previously Taken Indinavir


Official Title:

A Multicenter, Open-Label, Pilot Study to Evaluate the Safety and Activity of L-756423/Indinavir Sulfate, 800/400 Mg b.i.d. in Combination With Two nRTIs in HIV-Infected Patients Who Failed an Indinavir Containing Regimen


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

NIH AIDS Clinical Trials Information Service


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety Study, Primary Pu


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

30


Enrollment Type:


Study Dates

Verification Date:February 2000
Last Changed Date:June 23, 2005
First Received Date:January 17, 2000

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:L-756423
Intervention Type:Drug
Name:Indinavir sulfate

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Merck

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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