Simplified Drug Regimens for HIV Patients in ACTG 388 or Patients Who Responded to A First Potent Combination Regimen
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV-1, Didanosine, Drug Therapy, Combination, Zidovudine, Nevirapine, Stavudine, HIV Protease Inhibitors, Ritonavir, Lamivudine, RNA, Viral, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, ABT 378, Combivir, Efavirenz, Treatment Experienced
Eligibility Criteria
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
Sites / Locations
- Univ of Southern California / LA County USC Med Ctr
- Denver Dept of Health and Hosps
- Univ of Colorado Health Sciences Ctr
- Connecticut Children's Medical Center (Pediatric)
- Univ of Miami School of Medicine
- Emory Univ
- Queens Med Ctr
- Univ of Hawaii
- Northwestern Univ Med School
- Rush Presbyterian - Saint Luke's Med Ctr
- The CORE Ctr
- Indiana Univ Hosp
- Methodist Hosp of Indiana / Life Care Clinic
- Wishard Hosp
- Charity Hosp / Tulane Univ Med School
- Univ of Minnesota
- Washington Univ / St Louis Connect Care
- Washington Univ School of Medicine
- Univ of Nebraska Med Ctr
- SUNY / Erie County Med Ctr at Buffalo
- Cornell Clinical Trials Unit - Chelsea Clinic
- Bellevue Hosp / New York Univ Med Ctr
- Cornell Univ Med Ctr
- Univ of Rochester Medical Center
- Univ of North Carolina
- Duke Univ Med Ctr
- Univ of Cincinnati
- Case Western Reserve Univ
- MetroHealth Med Ctr
- Ohio State Univ Hosp Clinic
- Univ of Pennsylvania
- Univ of Washington
- Spedali Civili - Carosi
- Universita di Genova
- Ospedale Luigi Sacco Milazzo
- Universita degli Studi di Modena e Reggio Emilia
- Univ of Puerto Rico