A Study of Three Drug Combination Therapies in HIV-Infected Patients Who Have Never Been Treated With Anti-HIV Drugs
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| ClinicalTrials.gov Identifier: NCT00002407 |
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Recruitment Status :
Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infections | Drug: Indinavir sulfate Drug: Nevirapine Drug: Lamivudine Drug: Stavudine Drug: Didanosine | Not Applicable |
In this open-label, strategic study patients are evaluated at Weeks 0, 1, 2, 4, 8, 12 to Week 48 after being treated on one of the following regimens:
Stavudine (d4T) + Didanosine (ddI) + Lamivudine (3TC) or d4T + ddI + Indinavir or d4T + ddI + Nevirapine.
| Study Type : | Interventional (Clinical Trial) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized Open-Label Strategic Study to Evaluate the Safety and Efficacy of 3 Different Convergent and Divergent Drug Combination Therapies in Anti-Retroviral Naive HIV-1 Infected Patients With CD4+ Counts Above 200/mm3 |
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
- Diagnosed asymptomatic HIV infection.
- HIV-1 RNA greater than 500 copies/ml.
- CD4+ T-cell count greater than 200/mm3.
- Never received antiretroviral therapy.
Exclusion Criteria
Co-existing Condition:
Excluded:
Severe non-HIV-related disease.
Patients with the following prior conditions are excluded:
History of neuropathy.
Prior Medication:
Excluded:
- Investigational drug within 1 month prior to study.
- Immunomodulatory drug within 1 month prior to study.
Prior Treatment:
Excluded:
- Radiation therapy within past month.
- Chemotherapy within past month.
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): NCT00002407
| United States, New York | |
| Cornell AIDS Clinical Trials Unit | |
| New York, New York, United States, 10021 | |
Publications:
| ClinicalTrials.gov Identifier: | NCT00002407 History of Changes |
| Other Study ID Numbers: |
ATLANTIC STUDY |
| First Posted: | August 31, 2001 Key Record Dates |
| Last Update Posted: | June 24, 2005 |
| Last Verified: | November 1998 |
Additional relevant MeSH terms:
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HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Lamivudine Nevirapine Stavudine Didanosine Indinavir |
Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents Cytochrome P-450 CYP3A Inducers Cytochrome P-450 Enzyme Inducers Antimetabolites HIV Protease Inhibitors Protease Inhibitors |