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

This study has been completed.

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)


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.

Condition Treatment or Intervention
HIV Infections
 Drug: lopinavir/ritonavir
 Drug: lamivudine/zidovudine
 Drug: efavirenz
 Drug: lamivudine
 Drug: stavudine
 Drug: zidovudine
 Drug: didanosine

MedlinePlus related topics:  AIDS

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Factorial Assignment, Safety/Efficacy Study

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

Further Study Details: 

Expected Total Enrollment:  240

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.


Ages Eligible for Study:  13 Years and above,  Genders Eligible for Study:  Both


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

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

Location Information

      Univ of Southern California / LA County USC Med Ctr, Los Angeles,  California,  900331079,  United States

      Univ of Colorado Health Sciences Ctr, Denver,  Colorado,  80262,  United States

      Denver Dept of Health and Hosps, Denver,  Colorado,  80262,  United States

      Connecticut Children's Medical Center (Pediatric), Farmington,  Connecticut,  06030-3805,  United States

      Univ of Miami School of Medicine, Miami,  Florida,  331361013,  United States

      Emory Univ, Atlanta,  Georgia,  30308,  United States

      Queens Med Ctr, Honolulu,  Hawaii,  96816,  United States

      Univ of Hawaii, Honolulu,  Hawaii,  96816,  United States

      Northwestern Univ Med School, Chicago,  Illinois,  60611,  United States

      Rush Presbyterian - Saint Luke's Med Ctr, Chicago,  Illinois,  60612,  United States

      The CORE Ctr, Chicago,  Illinois,  60612,  United States

      Indiana Univ Hosp, Indianapolis,  Indiana,  462025250,  United States

      Methodist Hosp of Indiana / Life Care Clinic, Indianapolis,  Indiana,  46202,  United States

      Wishard Hosp, Indianapolis,  Indiana,  46202,  United States

      Charity Hosp / Tulane Univ Med School, New Orleans,  Louisiana,  70112,  United States

      Univ of Minnesota, Minneapolis,  Minnesota,  55455,  United States

      Washington Univ School of Medicine, St. Louis,  Missouri,  63108,  United States

      Washington Univ / St Louis Connect Care, Saint Louis,  Missouri,  63108,  United States

      Univ of Nebraska Med Ctr, Omaha,  Nebraska,  681985130,  United States

New York
      Univ of Rochester Medical Center, Rochester,  New York,  14642,  United States

      Bellevue Hosp / New York Univ Med Ctr, New York,  New York,  10016,  United States

      Cornell Univ Med Ctr, New York,  New York,  10021,  United States

      SUNY / Erie County Med Ctr at Buffalo, Buffalo,  New York,  14215,  United States

      Cornell Clinical Trials Unit - Chelsea Clinic, New York,  New York,  10011,  United States

North Carolina
      Univ of North Carolina, Chapel Hill,  North Carolina,  275997215,  United States

      Duke Univ Med Ctr, Durham,  North Carolina,  27710,  United States

      Case Western Reserve Univ, Cleveland,  Ohio,  44106,  United States

      Univ of Cincinnati, Cincinnati,  Ohio,  452670405,  United States

      Ohio State Univ Hosp Clinic, Columbus,  Ohio,  432101228,  United States

      MetroHealth Med Ctr, Cleveland,  Ohio,  441091998,  United States

      Univ of Pennsylvania, Philadelphia,  Pennsylvania,  19104,  United States

      Univ of Washington, Seattle,  Washington,  98104,  United States

      Spedali Civili - Carosi, Brescia,  Italy

      Universita di Genova, Genova,  Italy

      Universita degli Studi di Modena e Reggio Emilia, Modena,  Italy

      Ospedale Luigi Sacco Milazzo, Milano,  Italy

Puerto Rico
      Univ of Puerto Rico, San Juan,  009365067,  Puerto Rico

Study chairs or principal investigators

Margaret Fischl, MD,  Study Chair,  University of Miami   

More Information

Click here for more information about zidovudine.

Click here for more information about didanosine.

Click here for more information about stavudine.

Click here for more information about lamivudine.

Click here for more information about efavirenz.

Click here for more information about lamivudine/zidovudine.

Click here for more information about lopinavir/ritonavir.

Haga clic aquí para ver información sobre este ensayo clínico en español.


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.

Study ID Numbers:  ACTG A5116; AACTG 5116; Substudy AACTG A5124s; Substudy AACTG A5125s
Record last reviewed:  February 2005
Last Updated:  April 7, 2005
Record first received:  April 14, 2001 Identifier:  NCT00014937
Health Authority: United States: Federal Government processed this record on 2005-04-08

Cache Date: April 9, 2005