A Comparison of Epivir Plus Crixivan Combined With Zerit or Retrovir in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

To evaluate the tolerance, and comparative virologic and immunologic effects of the two combination regimens.

Completed

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hosp Regional de Ponce - Area Vieja, Ponce, Puerto Rico

About this study

100 patients will be randomized to receive Zerit (Stavudine) + Epivir (Lamivudine) + Crixivan (Indinavir) and 100 patients will be randomized to receive Retrovir (Zidovudine) + Epivir (Lamivudine) + Crixivan (Indinavir).

Patients will be treated for 48 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Indinavir sulfate

Drug

Lamivudine

Drug

Stavudine

Drug

Zidovudine

Drug

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

First posted: Aug 31, 2001
Registry last updated: Oct 2, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed