A Comparison of Two Anti-HIV Triple-Drug Combinations in HIV-Infected Patients

An Open Label, Randomized, Comparative Study of Zerit (d4T) + Videx (ddI) + Crixivan Versus Retrovir (AZT) + Epivir (3TC) + Crixivan in HIV-Infected, Antiretroviral Naive Subjects With CD4 Cell Counts of 200 - 700/mm3 and HIV RNA Baseline Copy Number of >= 10,000 Copies/ml

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00002168

Enrollment

200

Registered

2001-08-31

Start date

Unknown

Completion date

Unknown

Last updated

2007-10-02

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

Conditions

HIV Infections

Keywords

Didanosine, Drug Therapy, Combination, Zidovudine, Stavudine, HIV Protease Inhibitors, CD4 Lymphocyte Count, Lamivudine, Indinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load

Brief summary

The purpose of this study is to compare the safety and effectiveness of two anti-HIV drug combinations when given to HIV-infected patients who have never been treated with anti-HIV drugs. One drug combination is stavudine (d4T) plus didanosine (ddI) plus Crixivan. The other combination is Retrovir (AZT) plus Epivir (3TC) plus Crixivan.

Detailed description

100 patients will be randomized to receive Zerit (Stavudine) + Videx (Didanosine) + Crixivan (Indinavir) and 100 patients will be randomized to receive Retrovir (Zidovudine) + Epivir (Lamivudine) + Crixivan (Indinavir). Patients will be treated for 48 weeks.

Interventions

DRUGIndinavir sulfate

DRUGLamivudine

DRUGStavudine

DRUGZidovudine

DRUGDidanosine

Study design

Intervention model

PARALLEL

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

Inclusion criteria

Patients must have: * Documented HIV infection. * CD4 cell count of 200 - 700 cells/mm3.

Exclusion criteria

Co-existing Condition: Patients with the following symptoms or conditions are excluded: AIDS defining condition within 1 month of study entry. Prior Medication: Excluded: Patients with any history of antiretroviral therapy treatment.

Countries

Puerto Rico, United States

Outcome results

None listed

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