Study of Boosted Atazanavir (ATV) Versus Non-boosted ATV in Naive Patients
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ClinicalTrials.gov Identifier: NCT00084253 |
Recruitment Status
:
Completed
First Posted
: June 11, 2004
Last Update Posted
: March 5, 2010
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Atazanavir/ Stavidine / Lamivudine Drug: Atazanavir-Ritonavir/ Stavidine / Lamivudine | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase IV Study of Boosted Atazanavir (ATV) Versus Non-boosted ATV in Naive Patients |
Study Start Date : | June 2004 |
Actual Primary Completion Date : | August 2006 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1 |
Drug: Atazanavir/ Stavidine / Lamivudine
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.
Other Name: Reyataz
|
Active Comparator: 2 |
Drug: Atazanavir-Ritonavir/ Stavidine / Lamivudine
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.
Other Name: Reyataz
|
- 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).

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00084253
United States, New Jersey | |
Various locations within the US | |
Call for Information, New Jersey, United States |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
ClinicalTrials.gov Identifier: | NCT00084253 History of Changes |
Other Study ID Numbers: |
AI424-089 ST |
First Posted: | June 11, 2004 Key Record Dates |
Last Update Posted: | March 5, 2010 |
Last Verified: | June 2008 |
Keywords provided by Bristol-Myers Squibb:
HIV Treatment Naive |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Atazanavir Sulfate Lamivudine |
HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |