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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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lopinavir/ritonavir

Intervention Type DRUG

lamivudine/zidovudine

Intervention Type DRUG

efavirenz

Intervention Type DRUG

lamivudine

Intervention Type DRUG

stavudine

Intervention Type DRUG

zidovudine

Intervention Type DRUG

didanosine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

* Acceptable methods of contraception
* Consent of parent or legal guardian if under 18 years of age

Exclusion Criteria

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

* 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

Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Margaret Fischl, MD

Role: STUDY_CHAIR

University of Miami

Locations

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Univ of Southern California / LA County USC Med Ctr

Los Angeles, California, United States

Site Status

Denver Dept of Health and Hosps

Denver, Colorado, United States

Site Status

Univ of Colorado Health Sciences Ctr

Denver, Colorado, United States

Site Status

Connecticut Children's Medical Center (Pediatric)

Farmington, Connecticut, United States

Site Status

Univ of Miami School of Medicine

Miami, Florida, United States

Site Status

Emory Univ

Atlanta, Georgia, United States

Site Status

Queens Med Ctr

Honolulu, Hawaii, United States

Site Status

Univ of Hawaii

Honolulu, Hawaii, United States

Site Status

Northwestern Univ Med School

Chicago, Illinois, United States

Site Status

Rush Presbyterian - Saint Luke's Med Ctr

Chicago, Illinois, United States

Site Status

The CORE Ctr

Chicago, Illinois, United States

Site Status

Indiana Univ Hosp

Indianapolis, Indiana, United States

Site Status

Methodist Hosp of Indiana / Life Care Clinic

Indianapolis, Indiana, United States

Site Status

Wishard Hosp

Indianapolis, Indiana, United States

Site Status

Charity Hosp / Tulane Univ Med School

New Orleans, Louisiana, United States

Site Status

Univ of Minnesota

Minneapolis, Minnesota, United States

Site Status

Washington Univ / St Louis Connect Care

St Louis, Missouri, United States

Site Status

Washington Univ School of Medicine

St Louis, Missouri, United States

Site Status

Univ of Nebraska Med Ctr

Omaha, Nebraska, United States

Site Status

SUNY / Erie County Med Ctr at Buffalo

Buffalo, New York, United States

Site Status

Cornell Clinical Trials Unit - Chelsea Clinic

New York, New York, United States

Site Status

Bellevue Hosp / New York Univ Med Ctr

New York, New York, United States

Site Status

Cornell Univ Med Ctr

New York, New York, United States

Site Status

Univ of Rochester Medical Center

Rochester, New York, United States

Site Status

Univ of North Carolina

Chapel Hill, North Carolina, United States

Site Status

Duke Univ Med Ctr

Durham, North Carolina, United States

Site Status

Univ of Cincinnati

Cincinnati, Ohio, United States

Site Status

Case Western Reserve Univ

Cleveland, Ohio, United States

Site Status

MetroHealth Med Ctr

Cleveland, Ohio, United States

Site Status

Ohio State Univ Hosp Clinic

Columbus, Ohio, United States

Site Status

Univ of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Univ of Washington

Seattle, Washington, United States

Site Status

Spedali Civili - Carosi

Brescia, , Italy

Site Status

Universita di Genova

Genova, , Italy

Site Status

Ospedale Luigi Sacco Milazzo

Milan, , Italy

Site Status

Universita degli Studi di Modena e Reggio Emilia

Modena, , Italy

Site Status

Univ of Puerto Rico

San Juan, , Puerto Rico

Site Status

Countries

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United States Italy Puerto Rico

References

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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. doi: 10.1086/422518. Epub 2004 Jul 30.

Reference Type BACKGROUND

PMID: 15356820 (View on PubMed)

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 efavirenz) increases limb fat but raises serum lipid levels: results of a prospective randomized trial (AIDS clinical trial group 5125s). J Acquir Immune Defic Syndr. 2007 Jun 1;45(2):193-200. doi: 10.1097/QAI.0b013e318042e204.

Reference Type RESULT

PMID: 17527093 (View on PubMed)