Clinical trial NCT00002168: A Comparison of Two Anti-HIV Triple-Drug Combinations in HIV-Infected Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: East Bay AIDS Clinic
state: California
city: Torrance
country: United States
facility: Harbor UCLA Med Ctr / Division of Immunology / N-24
state: California
city: Washington
country: United States
facility: Anderson Clinical Research
state: District of Columbia
city: Washington
country: United States
facility: George Washington Med Ctr / Clinical Trials Unit
state: District of Columbia
city: Chicago
country: United States
facility: Chicago Ctr for Clinical Research
state: Illinois
city: Chicago
country: United States
facility: Northwestern Univ
state: Illinois
city: Omaha
country: United States
facility: Univ of Nebraska
state: Nebraska
city: Chapel Hill
country: United States
facility: Univ of North Carolina / Infectious Disease Division
state: North Carolina
city: Charlotte
country: United States
facility: The Nalle Clinic / Clinical Research Dept
state: North Carolina
city: Philadelphia
country: United States
facility: Univ of Pennsylvania / Infectious Diseases Division
state: Pennsylvania
city: Dallas
country: United States
facility: Southwest Infectious Disease Association / PA
state: Texas
city: Dallas
country: United States
facility: Univ of Texas Southwestern Med Ctr of Dallas
state: Texas
city: Ponce
country: Puerto Rico
facility: Hosp Regional de Ponce - Area Vieja
Study officials:
References: