indinavir-sulfate and Weight-Loss

To assess predictors for discontinuation and treatment-limiting adverse drug reactions (TLADR) among patients starting their first protease inhibitor (PI).. Data on patients starting a PI regimen (indinavir, ritonavir, ritonavir/saquinavir and saquinavir hard gel) in a randomized trial (RAS, n = 318) and an observational cohort (OBC, n = 505) were used to document reasons for discontinuation and TLADR. Risk factors for discontinuation of the initial PI/developing TLADR were assessed in Cox models.. A total of 43 (RAS) and 48% (OBC) discontinued the initial PI therapy within less than 2 years. In both populations TLADR were the most common reason for discontinuation. The incidence of TLADR in RAS was: 8.5 (indinavir), 66.0 (ritonavir), 15.6 (saquinavir hard gel) per 100 person-years of follow-up (P < 0.001). Body weight and type of PI initiated were independent risk factors for treatment discontinuation and TLADR in both groups. In OBC, the risk of developing TLADR increased by 12% per 5 kg lower body weight when starting the PI regimen [the relative hazard (RH) was 1.12 (95% confidence interval: 1.05-1.19) per 5 kg lighter], and starting ritonavir was associated with a three- to sixfold higher risk of TLADR relative to other PI regimens. Very similar results were documented in RAS [RH for body weight was 1.18 (1.07-1.29)].. Nearly half of the patients stopped treatment with the initial PI, most commonly as a result of adverse drug reactions. Low body weight and initiation of ritonavir relative to other PIs were associated with an increased risk of TLADRs. Very consistent results were found in a randomized trial and an observational cohort.

Topics: Adult; Cohort Studies; Female; HIV Infections; Humans; Indinavir; Male; Middle Aged; Predictive Value of Tests; Proportional Hazards Models; Protease Inhibitors; Randomized Controlled Trials as Topic; Risk Factors; Ritonavir; Saquinavir; Treatment Failure; Treatment Refusal; Weight Loss

The Community Research Initiative on AIDS is currently screening potential volunteers for clinical trials. Current studies include the effects of protease inhibitors on blood sugar, the effectiveness of twice a day Crixivan dosing, the effectiveness of adefovir dipivoxil in combination with protease inhibitors, the effectiveness of DMP 266 in combination with several drugs, and the effects of Oxandrolone on weight loss in women. Participants will be reimbursed after enrollment. Contact information and eligibility requirements are included.

Topics: Adenine; Alkynes; Anabolic Agents; Anti-HIV Agents; Benzoxazines; Blood Glucose; Clinical Trials as Topic; Cyclopropanes; Drug Therapy, Combination; Female; HIV Infections; HIV Protease Inhibitors; Humans; Indinavir; Male; Organophosphonates; Oxandrolone; Oxazines; Patient Selection; Reverse Transcriptase Inhibitors; Weight Loss