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A Study of Three Drug Combination Therapies in HIV-Infected Patients Who Have Never Been Treated With Anti-HIV Drugs

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00002407
Enrollment
Unknown
Registered
2001-08-31
Start date
Unknown
Completion date
Unknown
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Brief summary

The purpose of this study is to see if it is safe and effective to give one of three different triple-drug combinations to HIV-infected patients who have never been treated with anti-HIV drugs.

Detailed description

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.

Interventions

DRUGNevirapine
DRUGLamivudine
DRUGStavudine
DRUGIndinavir sulfate
DRUGDidanosine

Sponsors

Weill Medical College of Cornell University
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026