Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Call for Information, New Jersey


Purpose:

The purpose of this study is to find out if 300 mg of ATV plus 100 mg of ritonavir (RTV) works as well as 400 mg of ATV alone as part of a regimen with stavudine XR and lamivudine to slow or stop the progression of HIV infection in patients who have never used anti-HIV drugs.


Criteria:

Inclusion Criteria: - Signed Informed Consent - HIV RNA greater than or equal 200 copies/mL at screening - 18 years old or older - Must use barrier contraception - Women of child-bearing potential must have a negative serum or urine pregnancy test within 72 hours before beginning to take the study medications Exclusion Criteria: - Unable or unwilling to use acceptable method of birth control for the entire study period including 8 weeks after the study - Women using oral contraceptives, pregnant or breastfeeding women - Women who have a positive pregnancy test on enrollment or before beginning to take the study medications - People who have a life expectancy of greater than 12 months - Newly diagnosed HIV-related OI or any medical condition requiring acute therapy at the time of enrollment - Any antiretroviral therapy within 30 days prior to screening - Any prior antiretroviral therapy (greater than 30 days of NRTI and/or greater than 7 days of non-nucleoside reverse-transcriptase inhibitor (NNRTI) or protease inhibitor therapies) - Any of the following conditions: Cushings Syndrome, Gilbert's Syndrome, untreated hypothyroidism or hyperthyroidism, suspected primary (acute) HIV infection, obstructive liver disease, proven or suspected acute hepatitis in the 30 days prior to study entry, Intractable diarrhea (at greater than 6 loose stools per day for at least 78 consecutive days) within 30 days prior to study entry, history of hemophilia, history of acute or chronic pancreatitis, presence of cardiomyopathy (due to any cause) or any significant cardiovascular disease, such as unstable ischemic heart disease - Active alcohol or substance abuse - History or signs and symptoms of bilateral peripheral neuropathy greater than grade 2 at the time of screening - Previous therapy with myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic, or cytotoxic potential within 3 months of study start or the expected need for such therapy or therapy with methadone or ribavirin/interferons or treatment with neurotoxic drugs or drugs that affect CYP3A4 - Inability to swallow capsules


Study is Available At:


Original ID:

AI424-089 ST


NCT ID:

NCT00084253


Secondary ID:


Study Acronym:


Brief Title:

Study of Boosted Atazanavir (ATV) Versus Non-boosted ATV in Naive Patients


Official Title:

Phase IV Study of Boosted Atazanavir (ATV) Versus Non-boosted ATV in Naive Patients


Overall Status:

Completed


Study Phase:

Phase 4


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:

Bristol-Myers Squibb


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Para


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

200


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb

Study Dates

Start Date:June 2004
Primary Completion Date:August 2006
Primary Completion Type:Actual
Verification Date:June 2008
Last Changed Date:March 4, 2010
First Received Date:June 9, 2004

Study Outcomes

Outcome Type:Primary Outcome
Measure:To compare the proportion of subjects responding to treatment with HIV RNA levels < LOQ (400 c/mL) through Week 48 in treatment naive subjects for ATV and ATV/RTV (each combined with 3TC and d4T XR).
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Atazanavir/ Stavidine / Lamivudine
Description:Capsules, Oral, ATV (2 x 200 mg) QD + 3TC (2 x 150 mg) QD + Zerit XR (1 x 100 mg) QD, Once daily, 96 weeks.
Arm Name:1
Other Name:Reyataz
Intervention Type:Drug
Name:Atazanavir-Ritonavir/ Stavidine / Lamivudine
Description:Capsules, Oral, ATV (2 x 150 mg) QD + RTV (1 x 100 mg) QD + 3TC (2 x 150 mg) QD + Zerit XR (1 x 100 mg) QD*, Once daily, 96 weeks.
Arm Name:2
Other Name:Reyataz

Study Arms

Study Arm Type:Active Comparator
Arm Name:2
Study Arm Type:Active Comparator
Arm Name:1

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Bristol-Myers Squibb

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: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.