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NCT00000922 Clinical Trial

A Study to Evaluate the Long-Term Effectiveness of Three Anti-HIV Drug Regimens in HIV Infected Patients Who Have Never Been Exposed to Highly Active Antiretroviral Therapy (HAART)

HIV Infections Clinical Trial

Official title:
A Randomized, Open-Label Study of the Long-Term Effectiveness of Three Initial Highly Active Antiretroviral Therapy (HAART) Strategies in HAART-Niave, HIV-Infected Persons

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00000922
Other study ID # CPCRA 058
Secondary ID 11611
Status Completed
Phase N/A
First received November 2, 1999
Last updated April 16, 2014
Est. completion date June 2006

Study information
Verified date April 2014
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether it is better to start an anti-HIV regimen containing a protease inhibitor (PI), a non-nucleoside reverse transcriptase inhibitor (NNRTI), or a PI in combination with an NNRTI. This study will also examine which treatment regimen is best as a first treatment for HIV infection.

Description:

Highly active antiretroviral therapy (HAART) regimens containing PIs, NNRTIs, or nucleoside reverse transcriptase inhibitors (NRTIs) have been shown to slow disease progression. However, the long-term consequences of initial therapy with a PI, an NNRTI, or both a PI and an NNRTI are not yet known, nor is the impact on future anti-HIV treatment regimens. Patients who experience virologic failure on a particular HAART regimen typically have not been studied for subsequent response to other HAART regimens. It is possible that a regimen which is initially the most potent may not be optimal if it limits the effectiveness of subsequent anti-HIV treatment regimens.

Patients will be randomized to one of three HAART treatment arms:

- Arm 1 participants will receive one or two PIs plus two NRTIs.

- Arm 2 participants will receive one NNRTI plus two NRTIs.

- Arm 3 participants will receive one or two PIs plus an NNRTI plus one or two NRTIs.

Before randomization to a treatment arm, patients will be given the option of preselecting the drugs they will use or allowing randomization to study-specified drugs. The study-specified PIs will be indinavir (IDV), nelfinavir (NFV), or two PIs of patient and doctor choice. The study-specified NNRTIs will be nevirapine (NVP) or efavirenz (EFV). The study-specified NRTIs will be abacavir (ABC) plus lamivudine (3TC) or didanosine (ddI) plus stavudine (d4T).

The study sites will provide ABC, 3TC, ddI, or d4T to all patients who are assigned to take these medications. All other anti-HIV drugs for initial and subsequent treatment regimens are obtained by clinician prescription. At Months 1 and 4 and then every 4 months thereafter, patients will receive a medical history update, physical exam, and questionnaire. Blood samples will also be drawn to measure CD4 cell count, viral load, and genotypic antiretroviral resistance. Changes in treatment regimens may occur at any time.

Recruitment information / eligibility
Status Completed
Enrollment 1710
Est. completion date June 2006
Est. primary completion date January 2003
Accepts healthy volunteers No
Gender Both
Age group 13 Years and older
Eligibility Inclusion Criteria:

- HIV infected

- Agree to practice abstinence or to use barrier methods of birth control during the study

- Are at least 13 years old or have signed informed consent from legal guardian for patients between the ages of 13 and 18

Exclusion Criteria:

- Have ever taken any anti-HIV drugs

- Are unable to complete the study for any reason

- Pregnancy

- Breastfeeding

- Any condition that, in the investigator's opinion, may interfere with the study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Indinavir sulfate

• Abacavir sulfate

• Nelfinavir mesylate

• Efavirenz

• Nevirapine

• Lamivudine

• Stavudine

• Didanosine

Locations
Country Name City State
United States Partners in Research / New Mexico Albuquerque New Mexico
United States AIDS Research Consortium of Atlanta Atlanta Georgia
United States Southern New Jersey AIDS Cln Trials / Dept of Med Camden New Jersey
United States AIDS Research Alliance - Chicago Chicago Illinois
United States Denver CPCRA / Denver Public Hlth Denver Colorado
United States Henry Ford Hosp Detroit Michigan
United States Wayne State Univ - WSU/DMC / Univ Hlth Ctr Detroit Michigan
United States Univ TX Health Science Ctr Houston Texas
United States Yale Univ School of Medicine / AIDS Program New Haven Connecticut
United States Louisiana Comm AIDS Rsch Prog / Tulane Univ Med New Orleans Louisiana
United States Harlem AIDS Treatment Grp / Harlem Hosp Ctr New York New York
United States North Jersey Community Research Initiative Newark New Jersey
United States Philadelphia FIGHT Philadelphia Pennsylvania
United States The Research and Education Group Portland Oregon
United States Richmond AIDS Consortium / Div of Infect Diseases Richmond Virginia
United States Community Consortium / UCSF San Francisco California
United States Washington Reg AIDS Prog / Dept of Infect Dis Washington District of Columbia

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (7)

MacArthur RD, Chen L, Mayers DL, Besch CL, Novak R, van den Berg-Wolf M, Yurik T, Peng G, Schmetter B, Brizz B, Abrams D; CPCRA 058 FIRST Trial Study Team. The rationale and design of the CPCRA (Terry Beirn Community Programs for Clinical Research on AIDS — View Citation

MacArthur RD, Novak RM, Peng G, Chen L, Xiang Y, Hullsiek KH, Kozal MJ, van den Berg-Wolf M, Henely C, Schmetter B, Dehlinger M; CPCRA 058 Study Team; Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA). A comparison of three highly activ — View Citation

Moyle GJ, DeJesus E, Cahn P, Castillo SA, Zhao H, Gordon DN, Craig C, Scott TR; Ziagen Once-Daily in Antiretroviral Combination Therapy (CNA30021) Study Team. Abacavir once or twice daily combined with once-daily lamivudine and efavirenz for the treatment of antiretroviral-naive HIV-infected adults: results of the Ziagen Once Daily in Antiretroviral Combination Study. J Acquir Immune Defic Syndr. 2005 Apr 1;38(4):417-25. — View Citation

Ribera E, Rodríguez-Pardo D, Rubio M, Soler A, Pedrol E, Blanco JL, González A, Crespo M, Falcó V, Ocaña I, Deig E, Miró JM, Pahissa A. Efficacy and safety of once-daily combination therapy with didanosine, lamivudine and nevirapine in antiretroviral-naive HIV-infected patients. Antivir Ther. 2005;10(5):605-14. — View Citation

Shlay JC, Visnegarwala F, Bartsch G, Wang J, Peng G, El-Sadr WM, Gibert C, Kotler D, Grunfeld C, Raghavan S; Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA). Body composition and metabolic changes in antiretroviral-naive patients randomized to didanosine and stavudine vs. abacavir and lamivudine. J Acquir Immune Defic Syndr. 2005 Feb 1;38(2):147-55. — View Citation

Tedaldi EM, Absalon J, Thomas AJ, Shlay JC, van den Berg-Wolf M. Ethnicity, race, and gender. Differences in serious adverse events among participants in an antiretroviral initiation trial: results of CPCRA 058 (FIRST Study). J Acquir Immune Defic Syndr. — View Citation

van den Berg-Wolf M, Hullsiek KH, Peng G, Kozal MJ, Novak RM, Chen L, Crane LR, Macarthur RD; CPCRA 058 Study Team, the Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA), and The International Network for Strategic Initiative in Global — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Change in CD4 count from baseline to the average of all readings obtained at the regular follow-up visits beginning at Month 32
Primary time to disease progression, death, or CD4 count less than 200 cells/mm3 at the 4 Month visit for those patients with a baseline CD4 cell count of more than or equal to 200 cells/mm3
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