A Study of Increased Lactic Acid and Abnormal Fat Distribution in HIV-Positive Patients
HIV Infections, Lipodystrophy
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV-1, Zalcitabine, Didanosine, Drug Therapy, Combination, Zidovudine, Stavudine, Lamivudine, Blood, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Lipodystrophy, Combivir, Lactic Acid, abacavir
Eligibility Criteria
Inclusion Criteria Patients may be eligible for this study if they: Are HIV-positive. Are at least 18 years old. Agree not to have intercourse 2 weeks before, during, and 2 weeks after study or agree to use effective methods of birth control. Have had HIV-1 RNA levels less than 400 copies/ml on the 2 most recent measurements. Have at least 1 of the following situations: (a) at least 1 of the following: (1) decrease in facial fat, (2) decrease in fat in lower limbs, or (3) decrease in fat in buttocks area; or (b) an increase in lactate level greater than 2.2 mmol/L at the screening visit plus at least 1 of the following: (1) decrease in facial fat, (2) decrease in fat in lower limbs, or (3) decrease in fat in the buttocks area; or (c) an increase in lactate level greater than 2.2 mmol/L at screening visit plus at least 2 of the following: (1) shortness of breath, (2) weakness, (3) fast heartbeat, (4) recent weight loss (10 lbs. within the past 2 months), (5) pain and/or bloating in the abdomen, (6) nausea and/or vomiting and/or lack of appetite; or (d) lactate level greater than 3.2 mmol/L at the screening visit. Are able to read at a sixth-grade level. Have taken d4T consistently for the 6 months before entering study. Exclusion Criteria Patients will not be eligible for this study if they: Have diabetes or kidney failure. Have any condition that makes them unable to participate in this study. Are unable to take medications by mouth. Have serious medical conditions, such as congestive heart failure or other heart disease, which would affect the safety of the patient. Are taking or have taken abacavir plus Retrovir or Combivir. Are pregnant or breast-feeding. Are enrolled in other clinical studies. Have had a reaction to or are unable to take abacavir and have taken Retrovir in the past. Have taken hydroxyurea within the past 3 days or plan to take this drug during the study. Have had chemotherapy or radiation therapy within 4 weeks prior to screening visit (except for local treatment for Kaposi's sarcoma) or plan to have such treatment during the study. Have taken drugs that affect the immune system, such as systemic corticosteroids, interleukins, vaccines, or interferons, within 4 weeks prior to the screening visit. Have had an HIV vaccine within 3 months of the screening visit. Have taken recombinant Human Growth Hormone (r-hGH), megestrol acetate, medicines containing oxandrolone, oxymetholone, nandrolone, DHEA, or other testosterone derivatives, or glucocorticoids or other systemic steroids (except inhaled and topical steroids) in the last 4 months or plan to take these drugs during the study.
Sites / Locations
- THE Clinic
- Tower Infectious Disease Med Ctr
- St Lukes Medical Group
- UCSD Treatment Ctr
- Dupont Circle Physicians Group
- North Broward Hosp District / HIV Clinical Research
- Duval County Health Department
- Infectious Disease Research Institute Inc
- Northstar Med Clinic
- Jersey Shore Med Ctr
- South Jersey Infectious Diseases Inc
- Infectious Disease Specialists of NJ
- Bronx Veterans Affairs Med Ctr
- Infectious Diseases Assoc of Brooklyn
- Long Island College Hospital
- Mt Vernon Hospital
- Dr Lawrence Fontana
- Liberty Medical / Cabrini Hospital / Dept of Infec Diseases
- Howard Grossman
- Boriken Neighborhood Health Center
- Univ of North Carolina / SOCA
- Summa Health System
- Case Western Reserve Univ
- Philadelphia Veterans Administration Med Ctr
- Anderson Clinical Research
- Central Texas Clinical Research
- Gathe, Joseph, M.D.
- Diversified Med Practices, PA
- Univ of Texas / Med School at Houston
- Hampton Roads Med Specialists
- Swedish Med Ctr