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

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: Atazanavir/ Stavidine / Lamivudine (Drug); Atazanavir-Ritonavir/ Stavidine / Lamivudine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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).

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Various locations within the US, Call for Information, New Jersey, United States
Additional Information

BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm

Starting date: June 2004
Last updated: March 4, 2010

Page last updated: August 23, 2015

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