A Study of Three Different Anti-HIV Drug Combinations in HIV-Infected Patients
This study has been completed.
Sponsor:
Dupont Merck
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002410
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: November 1998
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Purpose
The purpose of this study is to compare the safety and effectiveness of three anti-HIV drug combinations. The three combinations are: (1) efavirenz (DMP 266) plus indinavir; (2) DMP 266 plus zidovudine (ZDV) plus lamivudine (3TC); and (3) indinavir plus ZDV plus 3TC. This study also examines the resistance HIV may have to these drugs and if these drugs are effective over a long period of time.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Indinavir sulfate Drug: Lamivudine Drug: Zidovudine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Primary Purpose: Treatment |
| Official Title: | A Phase III, Multicenter, Randomized, Open-Label Study to Compare Antiretroviral Activity and Tolerability of Three Different Combination Regimens (DMP 266 + Indinavir, DMP 266 + Zidovudine + Lamivudine, Indinavir + Zidovudine + Lamivudine) in HIV-Infected Patients |
Resource links provided by NLM:
Further study details as provided by NIH AIDS Clinical Trials Information Service:
Eligibility| Ages Eligible for Study: | 13 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Exclusion Criteria
Concurrent Medication:
Excluded:
- Terfenadine, astemizole, cisapride, triazolam, or midazolam (competition for the enzyme cytochrome P-450 3A4 [CYP3A4] by indinavir could result in inhibition of metabolic breakdown of these drugs and create the potential for serious and/or life threatening events [i.e., cardiac arrhythmia, prolonged sedation]).
- Rifampin or rifabutin (prohibited because of potential drug interaction with indinavir).
- Ketoconazole, itraconazole, and clarithromycin.
- Concomitant systemic therapy for acute opportunistic infection or malignancy.
Excluded:
Life expectancy less than 12 months.
Prior Medication:
Excluded:
- Prior treatment with efavirenz, 3TC, an NNRTI, or an HIV protease inhibitor.
- Prior antiretroviral agent within 14 days of initiating study treatment.
- Prior treatment (within 30 days of initiating study treatment) with any other experimental drug for any indication.
Patients must:
- Have a diagnosis of HIV infection.
- Have CD4 counts greater than or equal to 50 cell/mm3.
- Have a life expectancy greater than or equal to 12 months.
- Be post-pubescent.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002410
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| United States, Arizona | |
| Phoenix Body Positive | |
| Phoenix, Arizona, United States, 85016 | |
| Arizona Clinical Research Ctr Inc | |
| Tucson, Arizona, United States, 85712 | |
| United States, California | |
| Richard Stryker | |
| Beverly Hills, California, United States, 90210 | |
| Paul Cimoch | |
| Irvine, California, United States, 92618 | |
| AIDS Healthcare Foundation | |
| Los Angeles, California, United States, 90027 | |
| Oasis Clinic / Martin Luther Jr Gen Hosp / King-Drew Med Ctr | |
| Los Angeles, California, United States, 90059 | |
| Kraus Med Group | |
| Los Angeles, California, United States, 90036 | |
| United States, Connecticut | |
| Blick Med Associates | |
| Stamford, Connecticut, United States, 06901 | |
| United States, District of Columbia | |
| Novum Inc | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Florida | |
| Bach and Godofsky | |
| Bradenton, Florida, United States, 34205 | |
| Community Research Initiative of South Florida | |
| Coral Gables, Florida, United States, 33146 | |
| Boulevard Comprehensive Care Ctr | |
| Jacksonville, Florida, United States, 32209 | |
| Larry Marc Bush / c/o Sally Yantis | |
| Lake Worth, Florida, United States, 33463 | |
| Univ of Miami School of Medicine | |
| Miami, Florida, United States, 33136 | |
| Daniel Seekins | |
| Tampa, Florida, United States, 33614 | |
| Ctr for Quality Care | |
| Tampa, Florida, United States, 33609 | |
| Infectious Disease Research Institute | |
| Tampa, Florida, United States, 33614 | |
| Treasure Coast Infectious Disease Consultants | |
| Vero Beach, Florida, United States, 32960 | |
| United States, Georgia | |
| Georgia Research Associates | |
| Atlanta, Georgia, United States, 30342 | |
| Med College of Georgia | |
| Augusta, Georgia, United States, 30912 | |
| United States, Indiana | |
| Infectious Diseases | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Kentucky | |
| Univ of Kentucky Med Ctr | |
| Lexington, Kentucky, United States, 40536 | |
| United States, Missouri | |
| Kansas City AIDS Research Consortium | |
| Kansas City, Missouri, United States, 64111 | |
| United States, Nebraska | |
| Univ of Nebraska Med Ctr / HIV Clinic | |
| Omaha, Nebraska, United States, 681985400 | |
| United States, Nevada | |
| Univ Med Ctr / HIV Wellness Ctr | |
| Las Vegas, Nevada, United States, 89102 | |
| United States, New York | |
| Community Research Initiative on AIDS | |
| New York, New York, United States, 10001 | |
| Clinical Directors Network / HIV/AIDS Program Manager | |
| New York, New York, United States, 10011 | |
| United States, North Carolina | |
| Wake Forest Univ School of Medicine | |
| Winston Salem, North Carolina, United States, 27157 | |
| United States, Ohio | |
| Remington-Davis Inc | |
| Columbus, Ohio, United States, 43215 | |
| United States, Pennsylvania | |
| Philadelphia FIGHT | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, Rhode Island | |
| The Miriam Hosp | |
| Providence, Rhode Island, United States, 02906 | |
| United States, Texas | |
| Division of Infectious Disease / Dept of Internal Medicine | |
| Dallas, Texas, United States, 752359113 | |
| Research Services 2000 Inc | |
| Dallas, Texas, United States, 75208 | |
| Research Services 2000 Inc | |
| Fort Worth, Texas, United States, 76103 | |
| Montrose Clinic | |
| Houston, Texas, United States, 77006 | |
| UT-Health Science Ctr | |
| Houston, Texas, United States, 77030 | |
| Diagnostic Clinic of San Antonio | |
| San Antonio, Texas, United States, 78229 | |
| United States, Virginia | |
| Oyster Point Med Specialists | |
| Newport News, Virginia, United States, 23606 | |
| United States, Washington | |
| Novum Inc / Pharmaceutical Research Services | |
| Seattle, Washington, United States, 98122 | |
| United States, Wisconsin | |
| Infectious Diseases Associates | |
| Milwaukee, Wisconsin, United States, 53215 | |
| Puerto Rico | |
| Javier O Morales Ramirez | |
| San Juan, Puerto Rico, 00909 | |
Sponsors and Collaborators
Dupont Merck
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00002410 History of Changes |
| Other Study ID Numbers: | 281B, DMP 266-006 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
|
HIV-1 Drug Therapy, Combination Zidovudine Drug Resistance, Microbial HIV Protease Inhibitors |
Lamivudine Indinavir Genotype Reverse Transcriptase Inhibitors efavirenz |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Zidovudine Lamivudine Reverse Transcriptase Inhibitors |
Indinavir HIV Protease Inhibitors Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents Protease Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013