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NCT00014937 Clinical Trial

Simplified Drug Regimens for HIV Patients in ACTG 388 or Patients Who Responded to A First Potent Combination Regimen

HIV Infections Clinical Trial

Official title:
A Randomized, Controlled Trial of Two Potent, Simplified Regimens Utilizing A Protease Inhibitor-Sparing Regimen Versus A Nucleoside-Sparing Regimen for HIV-Infected Subjects Who Participated in ACTG 388 or Who Responded to A First Potent Combination Regimen and Have 200 or Less HIV-1 RNA Copies/ml

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00014937
Other study ID # A5116
Secondary ID AACTG 5116Substu
Status Completed
Phase N/A
First received April 14, 2001
Last updated July 26, 2013

Study information
Verified date July 2013
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

ACTG 388 was a clinical trial that compared three- and four-drug anti-HIV drug regimens and demonstrated the effectiveness of a three-drug regimen. This study will compare the ability of two different three-drug anti-HIV drug regimens to reduce levels of HIV in the blood. The study will also evaluate whether patients discontinue the regimens because of drug side effects.

Description:

ACTG 388 was designed to evaluate two four-drug regimens compared with a three-drug regimen in patients who were relatively treatment naive. Based on the increased complexity and toxicity of four-drug regimens and the resultant negative impact on response as compared with three-drug regimens, studies evaluating simplified potent regimens appear warranted. This study will evaluate simpilified drug regimens designed to enhance virologic activity without necessarily increasing the number of antiretroviral drugs. The study regimens will be assessed for both virologic control and tolerability. The study population will include patients previously enrolled in ACTG 388 and patients with prior advanced HIV disease who received and responded to potent antiretroviral therapy without evidence of virologic relapse.

Patients will be stratified according to ACTG 388 treatment or non-ACTG 388 study participation. Patients will then be randomized to receive either a protease inhibitor (PI)-sparing regimen of 2 nucleoside reverse transcriptase inhibitors (NRTIs) with efavirenz (EFV) (Arm I) or an NRTI-sparing regimen of EFV with lopinavir/ritonavir (LPV/r) (Arm II). Arm I options are enteric-coated didanosine (ddI-EC) plus lamivudine (3TC), ddI-EC plus zidovudine (ZDV), ZDV plus 3TC (or Combivir), stavudine (d4T) plus 3TC, or ddI-EC plus d4T (with exceptions as noted in the protocol). Only LPV/r, EFV, d4T, and ddI are provided by the study; other medications are obtained by nonstudy prescription.

All patients are evaluated for safety and for virologic and immunologic responses at Weeks 4 and 8, then every 8 weeks until the study ends. In addition, all patients have assessments for fat redistribution, fasting lipid profiles, fasting insulin levels, venous lactate levels, and treatment adherence. Patients will be followed for 1.5 to 3 years. Interim safety analyses will be conducted in June 2002 and June 2003. Patients in this study may also enroll in A5125s, a fat distribution and bone mineral density substudy.

Recruitment information / eligibility
Status Completed
Enrollment 240
Est. completion date
Est. primary completion date December 2004
Accepts healthy volunteers No
Gender Both
Age group 13 Years and older
Eligibility Inclusion Criteria for ACTG 388 Participants

- HIV-1 RNA level <= 200 copies/ml within 70 days of study entry

- Stable anti-HIV drug plan without harmful drug side effects or serious illness at the time of study entry

Inclusion Criteria for Non-ACTG 388 Participants

- Potent anti-HIV drug regimen as a first HIV treatment for at least 18 months

- HIV-1 RNA level >= 80,000 copies/ml or CD4+ count <= 200 cells/mm3 prior to starting anti-HIV drug regimen

- HIV-1 RNA level <= 400 copies/ml (or less than 500 copies/ml by bDNA) within 32 weeks of initial therapy

- HIV-1 RNA level <= 200 copies/ml within 60 days of study entry

Inclusion Criteria for Both ACTG 388 and Non-ACTG 388 Participants

- Acceptable methods of contraception

- Consent of parent or legal guardian if under 18 years of age

Exclusion Criteria for ACTG 388 Participants

- Viral resistance to study drugs as determined by resistance studies during ACTG 388

Exclusion Criteria for ACTG 388 and Non-ACTG 388 Participants

- Pregnancy or breastfeeding

- Certain heart medicines (flecainide or propafenone); antihistamines (astemizole and terfenadine); rifampin; ergot derivatives (dihydroergotamine, ergonovine, ergotamine, or methylergonovine); intestinal agents (cisapride); herbal products (St. John's wort); lovastatin or simvastatin; neuroleptics (pimozide); and sedatives/hypnotics (midazolam or triazolam)

- Allergy study drugs

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• lopinavir/ritonavir

• lamivudine/zidovudine

• efavirenz

• lamivudine

• stavudine

• zidovudine

• didanosine

Locations
Country Name City State
Italy Spedali Civili - Carosi Brescia
Italy Universita di Genova Genova
Italy Ospedale Luigi Sacco Milazzo Milano
Italy Universita degli Studi di Modena e Reggio Emilia Modena
Puerto Rico Univ of Puerto Rico San Juan
United States Emory Univ Atlanta Georgia
United States SUNY / Erie County Med Ctr at Buffalo Buffalo New York
United States Univ of North Carolina Chapel Hill North Carolina
United States Northwestern Univ Med School Chicago Illinois
United States Rush Presbyterian - Saint Luke's Med Ctr Chicago Illinois
United States The CORE Ctr Chicago Illinois
United States Univ of Cincinnati Cincinnati Ohio
United States Case Western Reserve Univ Cleveland Ohio
United States MetroHealth Med Ctr Cleveland Ohio
United States Ohio State Univ Hosp Clinic Columbus Ohio
United States Denver Dept of Health and Hosps Denver Colorado
United States Univ of Colorado Health Sciences Ctr Denver Colorado
United States Duke Univ Med Ctr Durham North Carolina
United States Connecticut Children's Medical Center (Pediatric) Farmington Connecticut
United States Queens Med Ctr Honolulu Hawaii
United States Univ of Hawaii Honolulu Hawaii
United States Indiana Univ Hosp Indianapolis Indiana
United States Methodist Hosp of Indiana / Life Care Clinic Indianapolis Indiana
United States Wishard Hosp Indianapolis Indiana
United States Univ of Southern California / LA County USC Med Ctr Los Angeles California
United States Univ of Miami School of Medicine Miami Florida
United States Univ of Minnesota Minneapolis Minnesota
United States Charity Hosp / Tulane Univ Med School New Orleans Louisiana
United States Bellevue Hosp / New York Univ Med Ctr New York New York
United States Cornell Clinical Trials Unit - Chelsea Clinic New York New York
United States Cornell Univ Med Ctr New York New York
United States Univ of Nebraska Med Ctr Omaha Nebraska
United States Univ of Pennsylvania Philadelphia Pennsylvania
United States Univ of Rochester Medical Center Rochester New York
United States Washington Univ / St Louis Connect Care Saint Louis Missouri
United States Univ of Washington Seattle Washington
United States Washington Univ School of Medicine St Louis Missouri

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

Countries where clinical trial is conducted

United States,  Italy,  Puerto Rico, 

References & Publications (2)

Demeter LM, Ribaudo HJ, Erice A, Eshleman SH, Hammer SM, Hellmann NS, Fischl MA; AIDS Clinical Trials Group Protocol 388. HIV-1 drug resistance in subjects with advanced HIV-1 infection in whom antiretroviral combination therapy is failing: a substudy of AIDS Clinical Trials Group Protocol 388. Clin Infect Dis. 2004 Aug 15;39(4):552-8. Epub 2004 Jul 30. — View Citation

Tebas P, Zhang J, Yarasheski K, Evans S, Fischl MA, Shevitz A, Feinberg J, Collier AC, Shikuma C, Brizz B, Sattler F; AIDS Clinical Trials Group (ACTG). Switching to a protease inhibitor-containing, nucleoside-sparing regimen (lopinavir/ritonavir plus efa — View Citation

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