BMS-Reyataz Study in Treatment in Naive Subjects to Compare the Efficacy and Safety Between Boosted Reyataz and Kaletra When in Combination With Fixed Dose Truvada

Not Applicable

• Conditions: -B20 Human immunodeficiency virus [HIV] disease resulting in infectious and parasitic diseases; Human immunodeficiency virus [HIV] disease resulting in infectious and parasitic diseases; B20

• Registration Number: PER-080-05
• Lead Sponsor: BRISTOL MYERS SQUIBB COMPANY,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-03-13
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1) Provide informed consent in writing, assess whether the patient is able to read and understand the content of informed consent.
2) Qualifying plasma level of HIV RNA> 5,000 c / ml.
3) Men and women over 18 years of age.
4) Women of childbearing age (FEM) should use a method of birth control that is appropriate.
5) Women of childbearing age must present a negative result in the pregnancy test performed in serum or urine.

Exclusion Criteria

1) WFAs that are not willing or able to use a method of birth control that is acceptable.
2) The WFAs that are using a prohibited contraceptive method.
3) Pregnant or lactating women.
4) Women who have obtained a positive result in the pregnancy test.
5) Presence of newly diagnosed HIV-related opportunistic infection, or any clinical condition that requires acute therapy at the time of enrollment.
6) Suspected primary infection (acute) due to HIV.
7) Any antiretroviral therapy in the 30 days prior to selection.
8) Previous antiretroviral therapy for> 1 week.
9) Subjects with Cushing´s syndrome.
10) Untreated hypothyroidism or hyperthyroidism.
11) Recent therapy with drugs that have a significant myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic or cytotoxic potential in the previous 3 months.
12) Subjects with obstructive liver disease.
13) Active abuse of alcohol or substances that is sufficient to prevent adequate compliance with the therapy under study, or may increase the risk of developing pancreatitis or drug hepatitis.
14) Acute hepatitis proven or suspected within 30 days prior to admission to the study.
15) Intractable diarrhea during the 30 days prior to admission to the study.
16) Impossibility of swallowing the capsules.
17) Active peripheral neuropathy.
18) Presence of cardiomyopathy or of any significant cardiovascular disease.
19) Clinically significant known disease of the cardiac conduction system.
20) Moderate to severe hepatic insufficiency.
21) Laboratory values ​​not acceptable in the selection.
22) Hypersensitivity to any of the ingredients of the study medication formula.
23) Receive any of the prohibited therapies.
24) Any other clinical condition or previous therapy that would make the patient unfit to continue in the study, or unable to meet the requirements of the treatment.
25) Prisoners or subjects who are compulsorily arrested may not be enrolled in this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified