A Study to Compare the Effects of Two Anti-HIV Drug Combinations on the Immune Systems of HIV-Infected Patients - Tabular View

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A Study to Compare the Effects of Two Anti-HIV Drug Combinations on the Immune Systems of HIV-Infected Patients

This study has been completed.

Study NCT00002448. Last updated on June 23, 2005. Information provided by NIH AIDS Clinical Trials Information Service

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

Descriptive Information Fields

Brief Title ^†

A Study to Compare the Effects of Two Anti-HIV Drug Combinations on the Immune Systems of HIV-Infected Patients

Official Title ^†

Evaluation of Immune Reconstitution in HIV Infected Patients Treated With Fortovase (Saquinavir) SGC QD Plus Ritonavir QD Plus 2 NRTIs Vs Efavirenz QD Plus 2 NRTIs

Brief Summary

The purpose of this study is to examine how the immune systems of HIV-infected patients react to 2 anti-HIV drug combinations.

Detailed Description

Patients are randomized to two study arms for at least 48 weeks of treatment. Arm A receives SQV SGC plus RTV plus two NRTIs of choice. Arm B receives EFV plus two NRTIs of choice. NRTIs approved for study use are stavudine (d4T), didanosine (ddI), zidovudine (AZT), lamivudine (3TC), Combivir, and zalcitabine (ddC). Abacavir is excluded. The following immunology variables and HIV-1 viral characteristics will be evaluated during study visits: CD4 and CD8 cell counts; naive and memory T-cells; T-cell activation markers (HLA-DR and CD38); T-cells expressing T helper 1- (TH1-) and T helper 2- (TH2-) associated intracytoplasmic cytokines; anti-CD3 T-cell activation responses; T-cell receptor V Beta repertoire; cytotoxic T-lymphocyte (CTL) activity levels; lymph node histology (optional); HIV-1 qualitative microcultures and viral phenotyping for non-syncytium-inducing (NSI) and syncytium-inducing (SI) viral isolates. Laboratory determinations, adverse effects, neurological exams (including mental status evaluations), and lipodystrophy parameters (including fasting lipid profile and physical parameters) also are evaluated.

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Parallel Assignment

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

HIV Infections

Intervention ^†

Drug: Ritonavir
Drug: Efavirenz
Drug: Saquinavir

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

October 1999

Completion Date

Eligibility Criteria ^†

Inclusion Criteria

Patients may be eligible for this study if they:

Are HIV-positive.
Have a viral load of at least 5,000 copies/ml and a CD4 cell count greater than 75 cells/mm3.
Are at least 16 (need consent of parent or guardian if under 18).
Are able to complete the study.

Exclusion Criteria

Patients will not be eligible for this study if they:

Have ever taken anti-HIV medications.
Are pregnant or breast-feeding.

Gender

Both

Ages

16 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00002448

Organization ID

229S

Secondary IDs ^††

M61028

Study Sponsor ^†

Hoffmann-La Roche

Collaborators ^††

Investigators ^†

Principal Investigator:	Mark Holodniy
Study Chair:	Joseph John
Study Chair:	Ronald Mitsuyasu

Information Provided By

NIH AIDS Clinical Trials Information Service

Verification Date

January 2001

First Received Date ^†

November 2, 1999

Last Updated Date

June 23, 2005

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