Lopinavir/Ritonavir in Combination With Saquinavir Mesylate or Lamivudine/Zidovudine to Explore Metabolic Toxicities in Antiretroviral HIV-Infected Subjects
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ClinicalTrials.gov Identifier: NCT00043953 |
Recruitment Status
:
Completed
First Posted
: August 19, 2002
Last Update Posted
: September 27, 2007
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Lopinavir/ritonavir Drug: Saquinavir mesylate Drug: Lamivudine/zidovudine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Study of Lopinavir/Ritonavir in Combination With Saquinavir Mesylate or Lamivudine/Zidovudine to Explore Metabolic Toxicities in Antiretroviral HIV-Infected Subjects |
Study Start Date : | August 2002 |

- Proportion of subjects with plasma HIV RNA level below 50 copies/mL [ Time Frame: 48 weeks ]

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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:
- Subject is naïve to antiretroviral treatment (subjects may not have more than 7 days of any antiretroviral treatment).
- Subject is at least 18 years of age, inclusive.
- If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control:condoms, sponge, foams, jellies, diaphragm or intrauterine device(IUD), a vasectomized partner, total abstinence from sexual intercourse
- If female, the results of a urine pregnancy test performed at screening (urine specimen obtained no earlier than 28 days prior to study drug administration) is negative.
- Subject is not breast-feeding.
- Vital signs, physical examination and laboratory results do not exhibit evidence of acute illness.
- Subject has no significant history of cardiac, renal, neurologic, psychiatric, oncologic, endocrinologic, metabolic or hepatic disease that would in the opinion of the investigator adversely affect his/her participating in this study.
- Subject does not require and agrees not to take any of the following medications for the duration of the study: midazolam, triazolam, terfenadine, astemizole, cisapride, pimozide, propafenone, flecainide, certain ergot derivatives (ergotamine, dihydroergotamine, ergonovine, and methylergonovine), rifampin, lovastatin, simvastatin, and St. John's wort.
- Subject agrees not to take any medication during the study, including over-the-counter medicine, alcohol or recreational drugs without the knowledge and permission of the principal investigator.
- Subject has not been treated for an active AIDS-defining opportunistic infection within 30 days of screening.
- Subject has a plasma HIV RNA level of greater than 400 copies/mL at screening.
- Subject agrees to take all doses of the study drug from the bottles provided by the sponsor (rather than other containers, i.e., "pill box").
- Subject has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), after the nature of the study has been explained and the subject has had the opportunity to ask questions. The informed consent must be signed before any study-specific procedures are performed.
Exclusion Criteria:
- Subject has a history of an allergic reaction or significant sensitivity to LPV/r, INV or Combivir.
- Subject has a history of substance abuse or psychiatric illness that could preclude adherence with the protocol.
-
Screening laboratory analyses show any of the following abnormal laboratory results:
- Hemoglobin ≤ 10.0 g/dL
- Absolute neutrophil count ≤ 1000 cells/µL
- Platelet count ≤ 50,000 per mL
- ALT or AST ≥ 3.0 x Upper Limit of Normal (ULN)
- Creatinine ≥ 1.5 x Upper Limit of Normal (ULN)
- Subject has received any investigational drug within 30 days prior to study drug administration.
- For any reason, subject is considered by the investigator to be an unsuitable candidate for the study.

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): NCT00043953
United States, California | |
AHF Research | |
Los Angeles, California, United States, 90015 | |
Stephen Becker, MD | |
San Francisco,, California, United States, 94115 | |
Pacific Horizon Medical Group | |
San Francisco, California, United States, 94115 | |
Harbor UCLA, Research & Education Institute | |
Torrance, California, United States, 90502 | |
United States, Massachusetts | |
Community Research Initiative of New England | |
Boston,, Massachusetts, United States, 02215 | |
Community Research Initiative of New England | |
Springfield, Massachusetts, United States, 01107 | |
United States, North Carolina | |
University of North Carolina at Chapel Hill | |
Chapel Hill,, North Carolina, United States, 27599 | |
The University of North Carolina at Chapel Hill | |
Chapel Hill, North Carolina, United States, 27599-7215 | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 | |
Canada | |
University of Ottawa at the Ottawa Health Research Institute | |
Ottawa,, Canada, K1H 8L6 | |
University of Ottawa Health Research Institute | |
Ottawa, Canada, K1H 8L6 |
Study Director: | Barbara A da Silva, M.D. | Associate Medical Director, Antiviral Global Project Team |
ClinicalTrials.gov Identifier: | NCT00043953 History of Changes |
Other Study ID Numbers: |
M01-384 |
First Posted: | August 19, 2002 Key Record Dates |
Last Update Posted: | September 27, 2007 |
Last Verified: | September 2007 |
Keywords provided by Abbott:
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 Lopinavir Saquinavir Lamivudine Zidovudine |
Lamivudine, zidovudine drug combination 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 Antimetabolites |